PEB - Pacific Edge Ltd

[Moneyman]

I was fortunate enough to buy between 7 and 11 cents a couple of years ago, and yes purchased more on each announcement. I was fortunate to bail out all but my free carry at 90 cents (after cap raise which I was a buyer with hopes for $2). PE owes me nothing, if it all goes belly up from here I will be OK. And yes I got back in at 6 cents and again at 10 cents as I believe it’s better equipped now than it was 2 years ago!

[Davexl]

Anyone got the goss on PEB NBR article this morning, key points ?

[winner69]

Anyone got the goss on PEB NBR article this morning, key points ?

Not much new stuff

As usual a lot based on analyst views ….with one saying cost cutting would be going backwards …need to run business as if nothing happened ……and incur heaps of lobbying / legal costs ….and capital raise likely next year …but to make that work possibly need a ‘strategic psrtner’

[Davexl]

Cheers winner, would love to be the eyes & ears at Harbour Asset Management also...

Was thinking that if all the companies affected by the LCD got together, they could spread the costs of suing Novitas, or for the lobbying and legal costs for starters...

[winner69]

Cheers winner, would love to be the eyes & ears at Harbour Asset Management also...

Was thinking that if all the companies affected by the LCD got together, they could spread the costs of suing Novitas, or for the lobbying and legal costs for starters...

Hard to say how many Harbour bought since announcement as SSH cover period from Jan but average buy about 20 cents so must have bought a few last week.

In the NBR story - Portfolio manager Shane Solly, in a carefully worded comment, says the fund manager is still waiting, along with everyone else, for what the company’s response to the game-changing decision will be. He says it has sufficient cash to keep going for now but would need to make significant changes to the business if it wants to keep going after that.

Hope Shane don’t talk to his Jarden mate who seems pretty down on PEB

[winner69]

Pretty insignificant ‘investment’ for Harbour now …just of bit of a plaything now

Cool playing with other peoples money

[Davexl]

Pretty insignificant ‘investment’ for Harbour now …just of bit of a plaything now

Cool playing with other peoples money

Hope no-one at Harbour was a bit "loose" at the time they made their "strategic" ?? decision to buy more...

[Ggcc]

Every day another 0.1 to 0.2 cents down. Yet people keep buying at open. If you want to get on board, buy at the end of the day and not the morning, or better yet maybe just stay out of PEB.... I for one am staying away unless they show something more positive. I see this hitting the actual floor again which was from memory 5 cents.

[Balance]

Looking like stock is heading towards 9c with buyers now getting filled fast by the big boys bailing out.

400m shares to go? :eek2:

Looking like it will finish on 9c today?

Buy side looking very thin indeed with punters running to the hills as the big boys keep bailing out at ever lower prices.

Less than 30,000 shares before the sp hits 9c.

After that, 7.5c is where it goes imo.

[Habits]

Looking like it will finish on 9c today?

Buy side looking very thin indeed with punters running to the hills as the big boys keep bailing out at ever lower prices.

Less than 30,000 shares before the sp hits 9c.

After that, 7.5c is where it goes imo.

BUT Bottomfeeder had an order for 40,000. Should have waited.

[bottomfeeder]

BUT Bottomfeeder had an order for 40,000. Should have waited.

Always difficult to buy at the bottom of any SP cycle. So easy in hindsight. I really hate smarter than thou hindsighters. So have to be prepared to either buy more as the price goes down or be happy with a small loss waiting for the reward further down the track. Down to. 093 at the moment. If $120 down on a buy is going to affect you to the extent that you want to be a smart ass troll, I would suggest you go back to bank deposits at lower than the inflation rate where you belong.

[bottomfeeder]

A big peev of mine is broker disuasion on a stock AFTER it goes down in price. My wife reads the Craig's newsletter and gave me full barrels when I was buying OCA at 67 cents when Craig's was lambasting OCA for just about anything they could imagine. That is until she became aware that those particular trades of OCA trading at 84 cents was what paid for her expensive new lounge suite. OK have admit I am still down a bit on OCA overall as I was buying in at 7O's before that, but you have to keep picking away at it bit by bit. As the Zen master said to his grasshopper "We will see" Nothing worse for an investor to be too scared to support your decisions because you are down a bit.

[Balance]

Looking like it will finish on 9c today?

Buy side looking very thin indeed with punters running to the hills as the big boys keep bailing out at ever lower prices.

Less than 30,000 shares before the sp hits 9c.

After that, 7.5c is where it goes imo.

9c gone and heading rapidly towards 8c.

Observe how the big boys suck the punters in?

[Habits]

Always difficult to buy at the bottom of any SP cycle. So easy in hindsight. I really hate smarter than thou hindsighters. So have to be prepared to either buy more as the price goes down or be happy with a small loss waiting for the reward further down the track. Down to. 093 at the moment. If $120 down on a buy is going to affect you to the extent that you want to be a smart ass troll, I would suggest you go back to bank deposits at lower than the inflation rate where you belong.

Indeed it is a difficult ask to buy at the bottom of the bottom, and have some w****er pointing out you didn't get it quite right. If you knew a couple of my recent trades you'd have rocks you could lob back at me. Thats why I am keeping that to myself. No offence intended bf, in fact I wish you all the best and a significant profit :cool:

[nztx]

9c gone and heading rapidly towards 8c.

Observe how the big boys suck the punters in?


ANZ still onboard with this mob ?

the way things are going they may soon be able to buy the lot for less than outlayed for first parcels :)

8.7c close today - any bets for tomorrow ? :)

[BigBob]

https://businessdesk.co.nz/article/markets/pacific-edges-american-dream?utm_source=7am+Headlines+from+BusinessDesk&utm_campaign=ef33698558-7am+Headlines&utm_medium=email&utm_term=0_617c2ef34a-ef33698558-446165824

[whatsup]

https://businessdesk.co.nz/article/markets/pacific-edges-american-dream?utm_source=7am+Headlines+from+BusinessDesk&utm_campaign=ef33698558-7am+Headlines&utm_medium=email&utm_term=0_617c2ef34a-ef33698558-446165824

Bob, can you post the unlocked version of this ?

[BigBob]

Bob, can you post the unlocked version of this ?

There's a 10 day free trial for all content.

For copyright reasons I can't post here...

[winner69]

Bob, can you post the unlocked version of this ?

Mostly about the last 20 years

Warning …..Might depress you if you read

[Sideshow Bob]

Warning …..Might depress you if you read

$297 million....!! :scared:

Disappointing as outside of the company/share perspective, you want companies like this to be successful from the human aspect - earlier detection of cancer and the benefits that brings.

[Davexl]

$297 million....!! :scared:

Disappointing as outside of the company/share perspective, you want companies like this to be successful from the human aspect - earlier detection of cancer and the benefits that brings.

Have worked for a medical devices company for about 7 1/2 years. They are now developing a brain implant to measure brain pressure wirelessly, to know if it's just a head-ache or a blocked drain. Anything involving the FDA in the US is likely to take $50 m minimum to get thru all 3 stages (human trials etc) - but $ 297 m and 20 odd years !

There's got to be something solid to come out of that kind of perserverance, both from PEB and its investors...price back up at 9c for now...

[Balance]

Amazes me how the punters in NZ have not worked out yet that PEB gets bought up in the mornings in recent times and then, gets sold down in the afternoon when the Ozzies come out to play.

Un-investable until PEB comes out with a coherent strategy sooner than later. Unbelievable that the company is caught like a possum in the headlights.

[Habits]

Amazes me how the punters in NZ have not worked out yet that PEB gets bought up in the mornings in recent times and then, gets sold down in the afternoon when the Ozzies come out to play.

Un-investable until PEB comes out with a coherent strategy sooner than later. Unbelievable that the company is caught like a possum in the headlights.

Buy in pm sell in am

I'm not a trader, would get caught out. You sound like a particularly good one Balance

[Ggcc]

Buy in pm sell in am

I'm not a trader, would get caught out. You sound like a particularly good one Balance
You don’t have to be a trader to understand the patterns

[Balance]

You don’t have to be a trader to understand the patterns

It is so obvious but many of the PEB punters probably think that PEB is soooo cheap? So close both eyes and bye buy bye.

[Balance]

And see how all the bids at 8.5c got taken out at the close?

The big boys are getting more and more impatient to get out every day there’s no update from PEB on revised strategy.

[BigBob]

Un-investable until PEB comes out with a coherent strategy sooner than later.

I do agree with you that at the moment it is un-investable, but it's not un-tradable.

Just like the PEB of a few years ago, it's one decent announcement away from a 50%+ bounce. And logically an announcement must come no later than the asm in late July...

[Balance]

I do agree with you that at the moment it is un-investable, but it's not un-tradable.

Just like the PEB of a few years ago, it's one decent announcement away from a 50%+ bounce. And logically an announcement must come no later than the asm in late July...

The big boys are bailing out and will take any bounce as an opportunity to continue to bail out imo.

But by all means trade the stock - PEB shares need all the liquidity it can get.

[Sideshow Bob]

Annual Report........

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/413482/396909.pdf

[whatsup]

Wasnt PEB test being in several hospitals in N Z, and with the decline of coverage in the U S Im wondering where they stand in regard to its reliability and necessity ?

[Balance]

Amazes me how the punters in NZ have not worked out yet that PEB gets bought up in the mornings in recent times and then, gets sold down in the afternoon when the Ozzies come out to play.

Un-investable until PEB comes out with a coherent strategy sooner than later. Unbelievable that the company is caught like a possum in the headlights.

Punters getting wise or shy at last and not lining up for the afternoon slaughter?

They are instead lining up at 8c today and there's every chance they will get filled by market close today imo.

[Balance]

Annual Report........

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/413482/396909.pdf

This should get some punters hot and excited in the AR :

"ADDRESSING A GLOBAL MARKET FOR OUR TESTS IS WORTH US$7.6 BILLION"

20 more years!

Just need DD back to sell that vision and raise more $$$$. :t_up:

[Balance]

Punters getting wise or shy at last and not lining up for the afternoon slaughter?

They are instead lining up at 8c today and there's every chance they will get filled by market close today imo.

Goodness me!

The 8c are gone! Taken out with more stock on the way! :scared:

The big boys are out early today - they obviously have read the AR with PEB's strategy for tackling the LCD crisis & are not impressed. :t_down:

https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcTbhgxIkXL4NWbaFP99BGxQgtV9eNsP6 mPtAw&usqp=CAU

[whatsup]

Whats the feeling that a U S enterprise could be building a stake in PEB what with its cash pile and all time low share price.
With todays ERD surprise T O announcement its not off the cards as anything is possible in this climate as dark as its immediate future looks there will be others out there who see value and a future possible in the U S with the right management and contacts.
Hmmmmmm !

[Balance]

Looking like it will finish on 9c today?

Buy side looking very thin indeed with punters running to the hills as the big boys keep bailing out at ever lower prices.

Less than 30,000 shares before the sp hits 9c.

After that, 7.5c is where it goes imo.

Gee - I posted that on Monday and PEB not only hit 7.5c today but finished the trading day at 7.3c.

So where does it go from here?

Hard to see any upside until the big boys stop selling (390m shares to go?) so it looks to me like 3 very painful years ahead for shareholders as the cash start running out.

PEB is on life support.

[kiwidollabill]

I've been keeping off this thread but watching from afar. So many people who know pharma, and had interactions with PEB are not at all surprised.

In my view this going to go from bad to worse....

If I was Kaiser, considering the very damming report which was published, I'd be reviewing CXbladder themselves....
All those new salespeople are going to see the writing on the wall that their targets/commissions are not going to happen and they will leave for greener pastures.

The annual report says PEB has done nothing wrong and Novatis is at fault (even throwing out that their view was that the judgement was illegal).

They just don't learn.....

[GTM 3442]

PEB turned out to be a good punt at 25c back in 2912. Will it be just as good at 5c this yeas?

[Sideshow Bob]

PEB turned out to be a good punt at 25c back in 2912. Will it be just as good at 5c this yeas?

"Punt" is the key word currently.....

[EmpatheticHuman]

hello everybody. I have been watching this thread for well over a decade now. the only commenter who has been close to what has happened at PEB happens to be Balance :). happened to have worked for PEB for almost 2 years under DD. when I left I contacted 2 different media outlets and the nzx. all declined to investigate. It takes maths and science to fully explain but 2 snippets are Negative predictive value (NPV) is 97% - sound good right...... well NO. in the instance of micro-hematuria the rate of bladder cancer is around 1.6% so (and we used to joke about this) if you assume every single person who presents with micro hematuria is negative (just an assumption with no testing) you would have a NPV of 98.4%. Positive predictive value - was originally 46.5% (1st study) and more recently has been as low as 16%. they never sing about this figure as even best case scenario of PPV 46.5% means if PEB advises a positive result. it is 53.5% likely you do NOT have bladder cancer. looks to me that novitas got it right. the tests are neither accurate nor required.

[Snoopy]

PEB turned out to be a good punt at 25c back in 2912. Will it be just as good at 5c this yeas?


Interesting comment from the time travelling contingent. Almost 900 years down the track and the PEB share price is still just 25c. So picking the bottom to be 5c (thanks again to the time traveller for giving us the heads up on this) :

5c(1+i)^887=25c => i= 1.001816 or 0.18% per year

so less than 0.2 of a percentage return per year, compounding over all that time! Better bring DD back quickly to keep that supporting capital flowing in. Probably best to lock in DDs descendants for a few hundred generations to ensure that long term capital raising plan as well.

SNOOPY

[Sideshow Bob]

Quite a decent sized article in the ODT this morning, albeit completely paywalled on their website.

One of the comments was "all hope is not lost". Looking at ways to challenge the decision.

Said that they always realised there was a chance of a negative outcome, and had alternate plans for such a case (no details). Peter Meintjes going to spend a bit of time in the US with their team.

Sorry only a brief skim read while trying to wolf down the cornies this morning......;)

[Davexl]

Quite a decent sized article in the ODT this morning, albeit completely paywalled on their website.

One of the comments was "all hope is not lost". Looking at ways to challenge the decision.

Said that they always realised there was a chance of a negative outcome, and had alternate plans for such a case (no details). Peter Meintjes going to spend a bit of time in the US with their team.

Sorry only a brief skim read while trying to wolf down the cornies this morning......;)

Excerpt from ODT:

Pacific Edge had the support of the American Cancer Society and also key opinion leaders and it was "hard to uncover" why Novitas had done it. Other companies were also affected.

For investors, it was a matter of waiting to see which path the company was going to take, after working through the various options with a balanced approach, and an update would be provided its annual meeting in Auckland next month, he said.

Dr Meintjes was basing himself in the US for the next few weeks while the company worked through the issue, particularly legal aspects.

The board and management team were exploring the full range of alternatives to either overturn or delay the LCD; regaining coverage through Novitas or through an alternative MAC; initiating alternative billing practices that would increase patient responsibility; and considering other strategic alternatives, including partnerships with other large biotech businesses.

[EmpatheticHuman]

noticed that DD is not in the significant shareholders list in the annual report - think he sold down?

[850man]

Quite a decent sized article in the ODT this morning, albeit completely paywalled on their website.

One of the comments was "all hope is not lost". Looking at ways to challenge the decision.

Said that they always realised there was a chance of a negative outcome, and had alternate plans for such a case (no details). Peter Meintjes going to spend a bit of time in the US with their team.

Sorry only a brief skim read while trying to wolf down the cornies this morning......;)

Surprised the CEO wasn't there earlier with 70% of their revenue at stake.

I see PEB are having their AGM on 27 July http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/413684/397187.pdf should be an interesting meeting.

[whatsup]

Looks like punters taking confidence in the ODT article and have moved the S P off its .072 bottom, now @ .085 ish, a good sign for the brave imo.

[snigmac]

If PEB can have the decision turned around or even for coverage to be extended until further research is available, a punt would be very lucrative. At worst, the shares don't have much further to fall.

If I apply a fairness stick, it looks like CxBladder and other tests were unfairly prejudiced due to a lack of understanding of the biomarkers. This does feel like a angle where PEB could have the decision turned around.

[Harrie]

If PEB can have the decision turned around or even for coverage to be extended until further research is available, a punt would be very lucrative. At worst, the shares don't have much further to fall.

If I apply a fairness stick, it looks like CxBladder and other tests were unfairly prejudiced due to a lack of understanding of the biomarkers. This does feel like a angle where PEB could have the decision turned around.

Bit of wishful thinking going on there,

[Habits]

Bit of wishful thinking going on there,

Rose tinted.

As with me, ten good trades and one shocker.

[bottomfeeder]

I bought some more at a lower price (I always grab a falling knife). If I sold now I would make $500. My wife says sell, sell, sell. $500 once used to be a weeks pay, now it doesnt pay for a new battery for my car. Got a quote from the dealer $890.08. Couldnt even round it down to $890. So inflation must be around 15%.

[snigmac]

This could be a moment to be greedy when others are fearful :). I doubt there will be a quick turn around, but oh boy, if there was a turnaround in q3/q4 this year, that would be grand and possibly realistic.

[whatsup]

Stronger close today , ( things to come ! )

[mr optimistic]

I hear the drum rollllll...................

[Greekwatchdog]

Trading halt pending....https://www.nzx.com/announcements/414369

[Balance]

Trading halt pending....https://www.nzx.com/announcements/414369

Let's hope this one is positive as the last two relating to LCD have been disastrous.

[bottomfeeder]

Must be good news. All the bad news has happened. Why would they reiterate what they they have already announced. 20cents by Monday.

[Balance]

Must be good news. All the bad news has happened. Why would they reiterate what they they have already announced. 20cents by Monday.

Long suffering shareholders deserve some relief.

Let's hope so.

[Mel]

Let's hope this one is positive as the last two relating to LCD have been disastrous.
This has come of the blue.....I've no idea what this could be, as any amendment to the decision by Novitas would take months (at best) I would have thought!

[Greekwatchdog]

Better news.. https://www.nzx.com/announcements/414371

[BigBob]

Pacific Edge Welcomes Stay of Novitas LCD
6/7/2023, 11:03 am GENERAL
PACIFIC EDGE WELCOMES STAY OF NOVITAS LCD

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today welcomes a decision from Novitas and First Coast to delay the implementation of the Local Coverage Determination (LCD, L35396) released in early June that would have seen Medicare coverage of Cxbladder cease in the US on 17 July 2023.

In an email received by Pacific Edge from our US lawyers, the US Department of Health and Human Services Associate General Counsel Janice L Hoffman said: "Details are being worked out but there is a commitment from these two MACs (same parent company) that the LCD will not proceed as is and that the LCD will go through the LCD process again with an open meeting and public comment period”.

No time frame has been provided for the process.

Pacific Edge Chief Executive Dr Meintjes said Pacific Edge was pleased with the outcome. Speaking from the USA, he said “we are confirmed in our position that a more robust procedure that includes open meeting and public comment was needed and thank Novitas for the opportunity to discuss the substance of their evidentiary review of Cxbladder products with them.

“We support efforts to ensure the Medicare program only pays for genetic testing services that are analytically valid, clinically valid, and clinically useful,” Dr Meintjes said.

“We will update investors as we gain further information on Cxbladder’s Medicare coverage status.”

Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.

[Greekwatchdog]

Well that is indeed a positive sign, not over the line by any stretch. So business as usual then.

[BigBob]

I do agree with you that at the moment it is un-investable, but it's not un-tradable.

Just like the PEB of a few years ago, it's one decent announcement away from a 50%+ bounce. And logically an announcement must come no later than the asm in late July...

I feel quietly chuffed about this one from a couple of weeks ago...

[Sampan]

Phew, I for one took that as an opportunity to cut my losses at a far better price than I would have been able to yesterday. I think most investors will see this as an opportunity to do the same. Its a dog of a stock and this situation is just so bloody unprofessional its not funny. Real mickey mouse in the way its played out. This will be back at 19 cents before we know it

[Balance]

I feel quietly chuffed about this one from a couple of weeks ago...

Much better than a 50% bounce so well done!

Our market can do with more positive announcements on more fronts.

[BigBob]

Much better than a 50% bounce so well done!

Our market can do with more positive announcements on more fronts.

Indeed - hopefully the first of many...!

[Balance]

Phew, I for one took that as an opportunity to cut my losses at a far better price than I would have been able to yesterday. I think most investors will see this as an opportunity to do the same. Its a dog of a stock and this situation is just so bloody unprofessional its not funny. Real mickey mouse in the way its played out. This will be back at 19 cents before we know it

Over 40m shares sold and bought during the sp collapse so it is indeed likely that there will be some great profit taking by the buyers as well as shareholders like you who see this bounce as an opportunity to bail out.

[Mel]

This has come of the blue.....I've no idea what this could be, as any amendment to the decision by Novitas would take months (at best) I would have thought!
Nice work by PEB (or should I say their lawyers) in achieving this holding pattern!!

[snigmac]

Profit takers will bail, but this company has legs and a great executive team! What a outstanding interim result! In the medium term, I'm thinking that the stock price should be around 30c once the market understands the positive news :) and of course after finer details are released.

The decision was clearly on the wrong side of the fairness stick!

[Davexl]

From Yesterdays 'Good Returns'

https://www.goodreturns.co.nz/article/976521859/auckland-international-airport-shares-stumble-all-eyes-on-fed.html?utm_source=ST&utm_medium=email&utm_campaign=ShareTrader+AM+Update+for+Thursday+15 +June+2023

"Harbour Asset Management picked up another 1% stake in cancer diagnostic firm Pacific Edge. The investment company already had a 13.5% stake but now has a total shareholding of 14.5%.

Pacific Edge’s shares slumped 89.9% last week on the news that the firm was likely to lose Medicare coverage of its Cxbladder tests in the US from mid-July.

“In for a penny,” Davies commented on Harbour’s move.
Pacific Edge’s stock was flat at 9.8 cents per share by early Wednesday evening"

They clearly see some value in PEB, perhaps from a buyout, IP already accumulated - anyway bought a lot yesterday - we'll see what happens...

Made a tidy fortune today, averaging 100% profit on 5 figure shares (000s).
Looks like fortune favours the brave (or the foolish, haven't made up my mind yet!)

Also looks like the lawyers got to Novitas (finally found a good use for them...);)

Nice to finally get some relief on an opportunity I expected to wait much longer for...

[barney]

It could be that Novitas have been pulled up by lawyers acting for PEB and other diagnostic companies regarding the process they have used in coming to a decision regarding coverage, hence they will go through the LCD process again. They may have got the process wrong but that in itself doesn't mean the outcome will change. The Novitas decision was fairly blunt in its assessment of PEB's research. I hope there is a different outcome but it's going to be a long wait.

[whatsup]

Phew, I for one took that as an opportunity to cut my losses at a far better price than I would have been able to yesterday. I think most investors will see this as an opportunity to do the same. Its a dog of a stock and this situation is just so bloody unprofessional its not funny. Real mickey mouse in the way its played out. This will be back at 19 cents before we know it

Re SP u picked it re sub .19 ish, did u load up again sub .19, fortune does favour the brave indeed !!!

[whatsup]

Re SP u picked it re sub .19 ish, did u load up again sub .19, fortune does favour the brave indeed !!!

This " game " aint over by a very long shot !!

[snigmac]

It could be that Novitas have been pulled up by lawyers acting for PEB and other diagnostic companies regarding the process they have used in coming to a decision regarding coverage, hence they will go through the LCD process again. They may have got the process wrong but that in itself doesn't mean the outcome will change. The Novitas decision was fairly blunt in its assessment of PEB's research. I hope there is a different outcome but it's going to be a long wait.

And based on the information, throughout the long wait, PEB will have coverage (this is the finer detail that will need to be expressly confirmed).

[bottomfeeder]

I bought some more at a lower price (I always grab a falling knife). If I sold now I would make $500. My wife says sell, sell, sell. $500 once used to be a weeks pay, now it doesnt pay for a new battery for my car. Got a quote from the dealer $890.08. Couldnt even round it down to $890. So inflation must be around 15%.

Lucky I don't listen to my wife. The $500 is now $9,800

[snigmac]

Lucky I don't listen to my wife. The $500 is now $9,800

The $9800 could be $15000 in the not too long future.

[bottomfeeder]

The $9800 could be $15000 in the not too long future.

Probably not likely. Just sold half, only 40k left. No one went broke taking a profit, even though there may be more in it. I am just waiting for a certain someone telling me I sold too soon.

[RGR367]

Probably not likely. Just sold half, only 40k left. No one went broke taking a profit, even though there may be more in it. I am just waiting for a certain someone telling me I sold too soon.

Good on you on making a profit! But you sold too soon. Lol

[Habits]

Those who sold at 30+ have done well in the short term. Cant say what will happen from here

[850man]

This update from PEB is confusing. It talks about delaying L35396 but this is an LCD from 2017 and states CXB is not covered. The more recent LCD where Novitas advises CXB coverage will cease on 17 July is L39365 and from what I can tell it is still active and not delayed. I have raised with PEB themselves asking for clarity.

[Mel]

This update from PEB is confusing. It talks about delaying L35396 but this is an LCD from 2017 and states CXB is not covered. The more recent LCD where Novitas advises CXB coverage will cease on 17 July is L39365 and from what I can tell it is still active and not delayed. I have raised with PEB themselves asking for clarity.
Good pick-up, look forward to their clarification

[BigBob]

There's no doubt it has been pulled...:

This is from Novitas' website:


Local Coverage Determination (LCD) and Article Update History for Jurisdiction L
July 6, 2023

The following LCD and related Billing and Coding Article, which was posted for Notice on June 2, 2023, will not become effective on July 17, 2023 as previously communicated. A new Proposed LCD will be published for comment and presented at an Open Meeting in the near future. Please continue to watch our website for updates.
Genetic Testing for Oncology (L39365)
Billing and Coding: Genetic Testing for Oncology (A59125)

https://www.novitas-solutions.com/webcenter/portal/MedicareJH/pagebyid?contentId=00006150

Also, for a bit of commentary on the LCD in general, check out the Discoveries in Health Policy blog...:


"A few weeks ago, NOVITAS and FCSO posted a massive new LCD for cancer biomarkers. As I noted at the time, the Final LCD was drastically longer than the proposed version (June 2022), a fact that seems to flaunt Medicare's requirement that LCDs go under notice and comment.

As I pointed out, it grew from 16 page to 68 and from 19 citations to 230. My blog here.

To almost no one's surprise, I think, CMS has called a halt to that nonsense.
Specifically, the final LCD did not resemble the proposed LCD.
Novitas is withdrawing the LCD, and says it will propose a new LCD for notice and comment in a meeting in the near future."...

Here's the Novitas remarks:

https://www.novitas-solutions.com/webcenter/portal/MedicareJH/pagebyid?contentId=00006150

Did The Massive Changes Run Afoul?

For Medicare regulations, CMS must post them for comment, and any variation in the final versio nmust be "a logical outgrowth" of the options proposed. Otherwise, a new comment period is triggered. While this law applies to CMS regulations, it makes sense that roughly analogous priniciples should apply to LCDs. If you must have a draft, a public comment, and a final, it's "no fair" to hold 95% of the content and denials to appear only in the final.

What Happens Next?

I suspect they will post the entire brontosaurus of an LCD for public comment, for 45 days. This exposes a lot of bloated and/or nonsensical and/or redundant text to public comment.

Will Coverage Change?

Coverage won't necessarily change. If they are opposed to covering certain test, and have the back up that they're not in guidelines or that private payors have mostly ruled "no," they can certainly propose and refinalize the 68 page version - if they want to.

With complaints on process, CMS can ask teh MAC to re-propose the LCD.
With complaints on "coverage decisions," historically CMS mostly tells complaining parties that if they dislike an LCD, by all means, apply for an NCD.
And by the way, they may add that NCDs are only open to FDA-approved tests.


https://www.discoveriesinhealthpolicy.com/2023/07/novitas-cancer-lcd-withdrawn-pending.html

[barney]

There's an article in today's NBR with some comments from one of Craig's analyst's regarding the murky nature of any final Novitas outcome from the revised process. Besides the new Novitas process another "significant tail risk has emerged" which involves the FDA intending to issue draft regulatory requirements by August this year for Laboratory Developed Tests which until now haven't required FDA approval.

[850man]

This update from PEB is confusing. It talks about delaying L35396 but this is an LCD from 2017 and states CXB is not covered. The more recent LCD where Novitas advises CXB coverage will cease on 17 July is L39365 and from what I can tell it is still active and not delayed. I have raised with PEB themselves asking for clarity.
PEB have now issued a correction to the announcement.

[bottomfeeder]

This update from PEB is confusing. It talks about delaying L35396 but this is an LCD from 2017 and states CXB is not covered. The more recent LCD where Novitas advises CXB coverage will cease on 17 July is L39365 and from what I can tell it is still active and not delayed. I have raised with PEB themselves asking for clarity.

Good Job 850man, you certainly pay attention to detail. Sold the balance of my holdings based on that announcement.

Now PEB change their announcement. Company stinks as far as I am concerned. This is important stuff. Maybe its good that I am out, made some money. 100% return within a month is good enough for me. May regret selling early, but wont regret the profit in my account, ever.

[snigmac]

It looks like Craig's have a 26c (now) and 57c (if coverage is not lost) valuation for PEB.

[mr optimistic]

I get the impression that Craig's has never been a big fan of PEB, especially since Forbar is. Almost feels slightly political. If PEB's coverage for BC and BS is reinstated, a valuation at 57c is a joke. Its north of $1.50

[850man]

Q1 test volumes increased over pervious periods. https://www.nzx.com/announcements/414829

[bottomfeeder]

Q1 test volumes increased over pervious periods. https://www.nzx.com/announcements/414829

Always amazes me when PEB makes their excellent percentage increase in turnover announcements. Large percentage announcements, but the actual number of tests is still way below what is nearly close to breakeven. This has been going on for years. I feel lucky I sold out, for even with the return to the status quo (possible?) they will find it difficult to get coverage necessary to meet profitability.

[Habits]

Always amazes me when PEB makes their excellent percentage increase in turnover announcements. Large percentage announcements, but the actual number of tests is still way below what is nearly close to breakeven. This has been going on for years. I feel lucky I sold out, for even with the return to the status quo (possible?) they will find it difficult to get coverage necessary to meet profitability.

Sh price following announcement

[barney]

https://www.nzherald.co.nz/business/stock-takes-call-for-pacific-edge-board-shake-up/UBHXHCYBCRHVJBWJTLJAD6VSYY/

Looks like some shareholders are looking for changes on the PEB board. For those of us who don't subscribe to the Herald, is anyone able to shed any light on this article.

[winner69]

https://www.nzherald.co.nz/business/stock-takes-call-for-pacific-edge-board-shake-up/UBHXHCYBCRHVJBWJTLJAD6VSYY/

Looks like some shareholders are looking for changes on the PEB board. For those of us who don't subscribe to the Herald, is anyone able to shed any light on this article.

Get their act together now rules have changed …..reduce number of directors to save costs ……use $2m of cash mountain to buy shares and hold as an incentive for management

Also said insiders need to show faith and buy shares

ASM could be interesting …nothing like a pack of peeved shareholders eh?

[barney]

Get their act together now rules have changed …..reduce number of directors to save costs ……use $2m of cash mountain to buy shares and hold as an incentive for management

Also said insiders need to show faith and buy shares

ASM could be interesting …nothing like a pack of peeved shareholders eh?

Cheers Winner.
I think you're right about the ASM, it will certainly be interesting. The company will have to show shareholders some clear strategies for the way forward if the Novitas decision does not change.

[Habits]

https://www.nzherald.co.nz/business/stock-takes-call-for-pacific-edge-board-shake-up/UBHXHCYBCRHVJBWJTLJAD6VSYY/

Looks like some shareholders are looking for changes on the PEB board. For those of us who don't subscribe to the Herald, is anyone able to shed any light on this article.

I wonder if you could make a herald sub tax deductible by requiring it as a necessary form of research

[whatsup]

I wonder if you could make a herald sub tax deductible by requiring it as a necessary form of research

Always is .

[mr optimistic]

didnt catch the full AGM. So what is the outcome. 4 years until we know if there is coverage. ??? Sounded like Kaiser is still fully committed, so could be some good data of their use of the the diagnostic at scale.

[winner69]

ASM doesn’t seem to have triggered a buying spree …. Bit disappointing was it

I see that Bryan Williams was re-elected as a Director ….he seems to have been around for ages.

[carrom74]

I thought it was a good ,open and a positive ASM. Loved the way the CEO kept adding his comments to the Q and A sometimes not directed at him,albeit sitting remotely. I see him as someone who is passionate and success driven.No share buyback nor a capital raise.

[Retired Doc]

didnt catch the full AGM. So what is the outcome. 4 years until we know if there is coverage. ??? Sounded like Kaiser is still fully committed, so could be some good data of their use of the the diagnostic at scale.

“Four more years!” ……..Heard that before!

[Sideshow Bob]

https://www.nzx.com/announcements/415392

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes the release overnight of a new proposed Local Coverage Determination (LCD) governing the reimbursement of its Cxbladder tests by Medicare, the US National Health Insurance provider.

The proposed LCD (DL39365) released by the Medicare Administrative Contractor (MAC) Novitas , notes the Cxbladder tests are ‘not considered medically reasonable and necessary’, the threshold required for coverage under the US Social Security Act. It follows substantially the same approach as the LCD ‘Genetic Testing for Oncology’ (L39365), which was released in early June and then withdrawn in early July following a concerted legal and political campaign from Pacific Edge and its industry partners that focused on several procedural issues.

Notably, and in contrast to the prior finalized LCD, Novitas has now provided for the statutory requirement for a 45-day notice and comment period commencing 27 July 2023* and finishing 9 September 2023*, during which time all interested stakeholders may submit comments to Novitas. The notice and comment period will also include an Open Public Meeting on 11 August 2023*, where Novitas has advised Pacific Edge in a direct communication that DL39365 is confirmed on the agenda.

Pacific Edge Chief Executive Dr Peter Meintjes said: “Pacific Edge supports Novitas’ efforts to ensure that Medicare only pays for analytically valid, clinically valid and clinically useful tests. Our Pacific Edge Diagnostics USA Team and our US-based Key Opinion Leaders (KOLs) are well prepared for the Novitas Open Meeting where we will focus on the clinical value of Cxbladder to Medicare patients in the context of the standard of care in urology and the importance of physician choice when determining patient care. We will summarize our published clinical evidence, maintaining the view that it is sufficient to support continued Medicare coverage for our Triage, Detect and Monitor tests.”

While the Open Public Meeting is an important part of the process, the written submissions are ultimately the most crucial, as Novitas is required to respond to all comments in a process that is also reviewed by the Centers for Medicare and Medicaid Services (CMS). Novitas may take up to 365 days from the original publication date (27 July 2023*) to withdraw or finalize the LCD including a response to those comments. When finalized, Novitas must provide a minimum of 45 days’ notice before the LCD becomes effective.

“We continue to believe the evidentiary review of DL39365 and its predecessor L39365 appear to misunderstand the intended use of the Cxbladder tests, which is to “rule out” patients who would otherwise receive an unnecessary cystoscopy and that this has significant clinical value to physicians, patients and payers like Medicare,” Dr Meintjes said.

“Pacific Edge and its KOLs will take the opportunity at the Open Meeting to present Novitas with important bladder cancer-specific medical knowledge regarding how clinical diagnostic tests such as Cxbladder with high negative predictive value, when used on patients that have a substantiated suspicion of cancer after presenting with hematuria, are a benefit to those patients and the Medicare Program.”

Pacific Edge is continuing to bill and receive reimbursement by Medicare and Medicare Advantage for its tests under reimbursement arrangements that have been in place since 2020.

The Draft LCD and the associated Local Coverage Article can be found at the CMS website here: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39667&ver=9&contractorName=6&contractorNumber=all&updatePeriod=1053&sortBy=updated&bc=13

Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.

*All dates with an Asterix refer to US dates

For more information:

[winner69]

Bob …..never understand what PEB go on about

Is this good or bad

My reading is just confirmation that things are still bad with Novitas ..but slim hope it may be Ok one day if PEB can change the view that Cxbladder tests are ‘not considered medically reasonable and necessary’,

[Balance]

Bob …..never understand what PEB go on about

Is this good or bad

My reading is just confirmation that things are still bad with Novitas ..but slim hope it may be Ok one day if PEB can change the view that Cxbladder tests are ‘not considered medically reasonable and necessary’,

They brought back DD to write that?

[Sampan]

Would someone at PEB please turn the bloody lights off and sub lease the offices ....

[Sideshow Bob]

Bob …..never understand what PEB go on about

Is this good or bad

My reading is just confirmation that things are still bad with Novitas ..but slim hope it may be Ok one day if PEB can change the view that Cxbladder tests are ‘not considered medically reasonable and necessary’,

That is why I have never bought into PEB, despite being in Dunners for a number of years and coming across various staff. I'm just a simple soul, but never fully understood or wanted to understand the process. Always thought regardless of how good the product is, the road to market and riches is full of unknowns (and potholes).

[Mel]

Bob …..never understand what PEB go on about

Is this good or bad

My reading is just confirmation that things are still bad with Novitas ..but slim hope it may be Ok one day if PEB can change the view that Cxbladder tests are ‘not considered medically reasonable and necessary’,
My interpretation is that by Novitas announcing this yesterday, they are now compliant procedurally (by providing the 45 day notice period). The only positive is that there is a scheduled 'open meeting' on 11 Aug where PEB can put forward their case - but I would suggest that the likelihood of a reversal in Novitas' decision within the short to medium-term is slim to none.

[Balance]

My interpretation is that by Novitas announcing this yesterday, they are now compliant procedurally (by providing the 45 day notice period). The only positive is that there is a scheduled 'open meeting' on 11 Aug where PEB can put forward their case - but I would suggest that the likelihood of a reversal in Novitas' decision within the short to medium-term is slim to none.

Last opportunity for shareholders to cut their losses and get the hell out imo.

[silu]

I'm one of those guys that despite decades of experience still throws some money at Biotechs that so far have always failed. It's not big money but I always hoped that one of them will make it big. Hopefully PEB will be the last straw and I continue to invest in companies I actually understand and make money from. But then can old dogs learn new tricks?

[winner69]

That is why I have never bought into PEB, despite being in Dunners for a number of years and coming across various staff. I'm just a simple soul, but never fully understood or wanted to understand the process. Always thought regardless of how good the product is, the road to market and riches is full of unknowns (and potholes).

….we’ve moved on from pot holes to sink holes it seems

[Balance]

I'm one of those guys that despite decades of experience still throws some money at Biotechs that so far have always failed. It's not big money but I always hoped that one of them will make it big. Hopefully PEB will be the last straw and I continue to invest in companies I actually understand and make money from. But then can old dogs learn new tricks?

The world needs people like you and I mean that sincerely.

[JSwan]

Interesting that it didn’t open at 5c this time

[bottomfeeder]

Interesting that it didn’t open at 5c this time

No but I am hoping it goes to 10cents and then I am in again.

[carrom74]

No but I am hoping it goes to 10cents and then I am in again.

Looks like your wish would eventuate.

[Grimy]

I'm one of those guys that despite decades of experience still throws some money at Biotechs that so far have always failed. It's not big money but I always hoped that one of them will make it big. Hopefully PEB will be the last straw and I continue to invest in companies I actually understand and make money from. But then can old dogs learn new tricks?

Same here........

[psychic]

The house built on sand?
For those hoping that PE may be able to win over Novitas and gain Medicare approval, I urge you to take the time to read part of the coverage decision, I found it completely alarming. I have copied it below as it seems utterly damning to me


Summary of Evidence for Specific Lab Tests

Cxbladder (Detect, Triage, Monitor, Resolve)

PubMed and Google Scholar were searched for peer-reviewed, evidence-based literature which provided information regarding analytic and clinical validity and clinical utility for the Cxbladder test. Key words used to search in combination included: Cxbladder, Cxbladder detect, Cxbladder triage, Cxbladder monitor, molecular testing, urine test, bladder cancer, urine biomarker(s), mRNA, uRNA, gene expression profile test, GEP test, 5 gene expression assay, prognostic, and TERT and FGFR3 mutations. Outside of publications from Pacific Edge Diagnostics or studies with funding from that company, only a few peer-reviewed papers have been published addressing the performance of Cxbladder tests.

The Cxbladder line of tests are currently represented by six variations on a five gene expression assay: Cxbladder Detect, Cxbladder Triage, Cxbladder Monitor, Cxbladder Resolve, enhanced Cxbladder Triage, and enhanced Cxbladder Detect. The sequential development of each test variant may be traced through a series of publications, beginning in 2008 with a paper describing the development of Cxbladder’s precursor, the uRNA test, a four gene expression profile (GEP) test.39 Each of the Cxbladder tests rely on a different set of statistical parameters to optimize the function of the five gene expression assay, sometimes synthesizing gene expression data with other inputted data such as patient demographics, cancer history, other clinical history, and single nucleotide variants associated with the FGFR3 and TERT genes. Cxbladder Detect is optimized for sensitivity and specificity as initially described in the seminal 2012 paper.40 Both Cxbladder Triage and Cxbladder Monitor are optimized for sensitivity, Negative Predictive Value (NPV), and test negative rate as initially described in 2015 and 2017 papers, respectively.41,42 Cxbladder Resolve, with a published validation in 2021, is optimized for sensitivity and specificity.43 Most recently, in 2022, the enhanced versions of Cxbladder Triage and Detect were described, with the basic purpose of each parent test unchanged but the parameters of each new test modified by adding data from sequencing six “single nucleotide polymorphisms” associated with two genes: FGFR3 and TERT.44

In 2008, Holyoake and colleagues described a precursor to the Cxbladder tests, uRNA.39 The four gene (CDC2, MDK, IGFBP5, and HOXA13) expression profile test was designed to detect and characterize transitional cell carcinoma (TCC) from patients’ urine. Development of the test involved selection of RNA expression markers that best detected and characterized both early and late stage TCC tumors. The best candidate markers were identified through comparison of tissue from 58 tumors of different stages (Ta-T4) and normal urothelial tissue. Validation of the test utilized urine samples from a cohort of 142 patients that was comprised of 75 patients who were diagnosed with Ta-T4 tumors and 77 “control” patients. The overall specificity of this test was 85% with a range of sensitivities depending on tumor stage (from 48% for Ta tumors to 100% for tumors with a stage greater than T1).

In 2012, O’Sullivan and colleagues developed and validated the first Cxbladder test (Cxbladder Detect), using a foundation of the uRNA four GEP test and adding an additional gene (CXCR2) to this profile.40 The 2012 publication also compared the new Cxbladder test to its precursor test (uRNA-D), urine cytology, and other urine tests on the market (NMP22 ELISA and BladderChek). The patient cohort was comprised of 485 patients presenting with gross hematuria. Cxbladder demonstrated an 81.8% sensitivity at a fixed specificity of 85%; all other tests in the comparison fell below a sensitivity of 65%, although the specificity of all other tests was higher than Cxbladder, with the highest specificity at 96.4% for the BladderChek test.

In 2015, Breen and colleagues further evaluated the Cxbladder Detect test in a comparative study with other tests used to detect urothelial carcinoma in urine.45 The other tests evaluated included cytology, UroVysion FISH, and NMP22. The study utilized five cohorts of patients, only one of which evaluated all four tests for the entire cohort. Data from the five cohorts were evaluated and integrated, with several different imputation analyses utilized to fill in for missing test values and create a “new, imputed, comprehensive dataset.” From this data, the authors found that before imputation, Cxbladder Detect had superior sensitivity (79.5%) as compared to the other three tests (the second highest sensitivity being 45.5%) but inferior specificity (82.2%), with the second lowest specificity being 87.3%. Utilizing several different imputation methodologies, similar findings for comparative sensitivities and specificities were seen, leading to the conclusion that the imputed data sets were valid, with the best imputation methodology being the 3NN model. Finally, with the new imputed data set, the authors re-assessed the comparisons between tests and found that Cxbladder Detect “outperformed” the other tests in this study.

In 2015, Kavalieris and colleagues developed another version of the Cxbladder test (later to be called Cxbladder Triage), this time evaluating the impact of adding clinical data (age, gender, frequency of macrohematuria, and smoking history) to the testing algorithm.41 Genetic input into the algorithm was termed the G INDEX while clinical data was termed the P INDEX. The study utilized 517 patients with macrohematuria from the 2012 Cxbladder study population, an additional 178 patients with macrohematuria from two separate cohorts, and 45 patients from a small cohort of patients with microhematuria.38 Combining the G and P indices provided a better bias-corrected receiver operating characteristic curve (AUC) (0.86) than either of the indices alone (0.83 and 0.61 respectively). When set at a test-negative rate of 0.4, the G + P INDEX performed with a sensitivity of 95% and NPV of 98%, improving on the G INDEX sensitivity and NPV of 86% and 96% respectively. The authors envisioned the G + P INDEX being used to triage outpatients with a low probability of having urothelial carcinoma, reducing the need for diagnostic procedures.

In 2017, Kavalieris and colleagues developed another version of the Cxbladder test (Cxbladder Monitor) utilizing a cohort of 763 patients under surveillance for recurrence of bladder urothelial carcinoma.42 In addition to the data from the five gene expression profile, Cxbladder Monitor also used clinical data in its algorithm which included previous tumor status (primary tumor or recurrent tumor) and the number of years elapsed since the previous tumor. The paper analyzed several subgroups including different stages of tumor and patients who had received adjuvant bacillus Calmette-Guerin (BCG) treatment. With a test negativity rate of 0.34, Cxbladder Monitor demonstrated a sensitivity of 93% and NPV of 97%.

Also from 2017, Lotan and colleagues utilized the same patient cohort found in the Kavalieris (2017) study to perform a comparative analysis between Cxbladder Monitor and other noninvasive urine tests that were used to rule out recurrent urothelial carcinoma.42,46 The authors found that Cxbladder “outperformed” all comparative tests (which included cytology, NMP22 ELISA, NMP22 BladderChek, and UroVysion FISH), with higher sensitivity (91% versus sensitivities ranging from 11% to 33%) and higher NPV (96% versus NPVs ranging from 86% to 92%).

In 2017, Darling and colleagues performed a clinical utility study for Cxbladder Triage and Detect.47 The study used previously obtained clinical data and Cxbladder test results to create clinical scenarios for twelve urologists. These scenarios centered on patients presenting with hematuria and evaluated how the urologists would hypothetically work-up these patients in the context of Cxbladder results. The study found that when the urologists had access to Cxbladder results, they would hypothetically change their clinical decisions in caring for these patients, ultimately leading to fewer invasive diagnostic procedures.

In 2018, Lough and colleagues performed a clinical utility study for Cxbladder Monitor.48 The study used previously obtained clinical data and Cxbladder test results to create clinical scenarios for eighteen physicians. These scenarios centered on patients with a history of urothelial carcinoma and evaluated how the physicians would hypothetically manage these patients in the context of Cxbladder results. The study found that when the physicians had access to Cxbladder results, they would hypothetically change their clinical decisions in caring for these patients, leading ultimately to fewer tests and procedures for patients classified as low risk by Cxbladder and an increased number of tests and procedures for patients classified as higher risk.

In 2019, Konety and colleagues performed a retrospective analysis of pooled data (from four patient cohorts) in the context of Cxbladder Triage, Detect, and Monitor.49 A total of 436 samples were evaluated from patients with hematuria and 416 samples from patients with potential recurrence of urothelial carcinoma. These Cxbladder results were then compared with cytology results for the same samples. The authors found that overall, Cxbladder demonstrated a better NPV than cytology (97.4% versus 92.6%) and missed less tumors (false negatives) than cytology (eight missed versus 59 missed).

In 2020, Koya and colleagues performed a retrospective audit of a new surveillance protocol that incorporated Cxbladder Monitor for patients with a history of urothelial carcinoma.50 The patients involved were divided into two cohorts: low risk (n = 161) and high risk (n = 47), noting that these numbers represent only patients who completed the study with both Cxbladder testing and follow up cystoscopy. There were 309 patients who were initially enrolled in the study but only 208 that completed the study. In the low-risk cohort, patients who received a negative result for the Cxbladder test were permitted to wait longer (12 months as opposed to within two to three months of a positive result) before receiving a follow-up cystoscopy. In the high-risk cohort, patients were managed the same regardless of the Cxbladder result, although the data was used to speculate on potential changes to the protocols for this type of patient. Over the course of the study and in the 35 months of the follow-up period, no cases positive for urothelial carcinoma were missed by the first Cxbladder test (although there was at least one false negative result in a second, follow-up round of Cxbladder testing) and no patients developed newly invasive or metastatic urothelial carcinoma. For the low-risk cohort, confirmed recurrence occurred in three of the patients who initially tested negative in the Cxbladder test; only two of those three patients had a follow-up, second Cxbladder test, with one true positive and one false negative (as demonstrated in the supplementary figures). There was confirmed recurrence in three low risk patients who tested positive with Cxbladder. For high risk patients, four patients demonstrated a recurrence of urothelial carcinoma and all four of these patients tested positive with Cxbladder.

In 2023, Li and colleagues evaluated Cxbladder Monitor through a prospective study of 92 patients diagnosed with non-muscle invasive bladder cancer (NMIBC) from two different clinical sites that were ready for follow up regarding their diagnosis (primary or recurrent), a previous procedural visit, and/or other therapy (e.g., BCG instillation).51 The study sought to triage scheduling these patients’ for follow-up cystoscopy through use of at home Cxbladder Monitor testing, delaying the follow-up appointment if patients received a lower risk score (<3.5) on the Monitor test. Patients with either gross hematuria or active UTI were excluded from the study. Moreover, of the 92 patients, a total of 16 were lost to follow-up, although data was still included in summary tables for these 16 patients. Of the 24 patients followed-up earlier due to a higher risk score (>3.5), nine were found to have tumors on cystoscopy. Of the 52 patients with delayed cystoscopy due to a lower risk score, none were found to have tumor. Note that of the 66 patients with a lower risk score, 14 were not evaluated via the delayed cystoscopy for the following reasons: did not show up for cystoscopy, chose another round of Cxbladder Monitor testing instead of cystoscopy, stopped surveillance for reasons not given, or died of “unrelated” but undescribed causes. The paper also noted that the patients who opted out of the follow-up cystoscopy in favor of a second Cxbladder Monitor test were only found at one of the two sites. The authors concluded that using at-home Cxbladder Monitor testing to triage patients and allow delayed cystoscopy for patients with a lower risk score was an effective new protocol.

In 2021, Raman and colleagues developed a fourth version of the Cxbladder test, Cxbladder Resolve, utilizing three different patient cohorts (total of 863 patients) in the internal validation and one separate cohort (548 patients) in the external validation.43 In the external validation, testing was also performed with other versions of the Cxbladder test: Cxbladder Triage and Detect.

Cxbladder Resolve was designed to identify patients with a high probability of high-impact tumors (HIT), namely high grade urothelial carcinomas, by stratifying patients into one of three categories: high priority for HIT evaluation, work-up for HIT based on physician-directed protocol (PDP), or manage by observation. In the internal validation, Cxbladder Resolve was found to have a bootstrap-adjusted estimated sensitivity of 92.4% and specificity of 93.8% for HIT; note that the overall sensitivity and specificity for all tumors during the internal validation was 91.2% and 61.0% respectively. In the external validation, Cxbladder Resolve correctly identified all HIT diagnoses and missed three low grade tumors, with a cumulative sensitivity of 90.0% and specificity of 96.3%. The authors also found that using a reflexive test algorithm with Cxbladder Triage, Detect, and Resolve together would correctly identify 87.6% of patients who did not need further work-up (NPV of 99.4%).

In 2022, Lotan and colleagues published a study describing two newer versions of the Cxbladder tests (enhanced Cxbladder Triage [CxbT+] and Detect [CxbD+]).46 The enhancement (digital droplet PCR testing of urine specimens) was used to identify the presence or absence of six single nucleotide polymorphisms (SNPs) associated with the genes FGFR3 and TERT. These SNPs, mostly somatic (acquired) genetic variants, can be found in urothelial carcinomas, as described in the literary references provided in Lotan and colleagues’ paper. Lotan and colleagues performed an internal validation of these new biomarkers, testing urine from two cohorts: 344 patients from the United States and 460 patients from Singapore. The six SNPs were evaluated both as stand-alone tests and as enhancement to original Cxbladder Triage and Detect tests. The authors concluded that the addition of the six SNPs to the Cxbladder tests improved test performance, particularly specificity.

Two publications from Davidson and colleagues in 2019 and 2020 evaluated the performance of the Cxbladder Triage test when integrated into hematuria work-up protocols.52,53 Notably, these studies were not performed or funded by Pacific Edge Diagnostics. The 2019 paper prospectively evaluated the new protocol without enacting it within the clinical setting while the 2020 paper described the outcome of a fully enacted protocol. In the 2019 study, which included 478 patients with hematuria referred to the urology practice and 73 patients with hematuria who had not been referred, the Cxbladder test correctly triaged 42 of 44 patients with urothelial malignancy; the two false negatives were either confirmed or suspected (no histology obtained) low grade lesions. From their cohort, the authors found that Cxbladder Triage had a sensitivity of 95% and NPV of 98%. The authors concluded “the risk of missing a significant cancer from the adoption of the theoretical pathway appears very low and clinically acceptable,” while later stating that larger studies were still needed to “prove the true clinical value of inclusion of these biomarkers in investigative pathways.” In the 2020 study, Davidson and colleagues retrospectively evaluated the clinical courses of 884 patients with hematuria who were worked-up with the new protocol and subsequently followed for a median of 21 months. The protocol identified 46 histologically confirmed urothelial carcinomas. Cxbladder Triage results included five false negatives, four of which were detected upon imaging and one of which was discovered in a three month follow up. Cxbladder Triage results also demonstrated low specificity with 39% of results being false positives. Overall, the authors found that the protocol that included Cxbladder Triage had a sensitivity of 98.1% and NPV of 99.9%. The authors concluded that their findings “add to the increasing evidence that biomarkers have a place in the assessment of hematuria, but that the results of these assays need to be supported by imaging of the bladder.”

In terms of systemic reviews and meta-analyses, two publications in 2015 were identified, both from Chou and colleagues, in contract with the Agency for Healthcare Research and Quality, AHRQ, U.S. Department of Health and Human Services.54,55 The publications discussed several urinary biomarker tests including Cxbladder Detect. However, both publications only discussed a single Cxbladder study performed by O’Sullivan and colleagues in 2012.40 In the shorter publication by Chou and colleagues, a systematic review and meta-analysis in the Annals of Internal Medicine, the sensitivity and specificity of Cxbladder was given a low grade for strength of evidence (as determined by study quality, precision, consistency and directness). The process of evidence assessment was covered in greater detail in the 923 page document from Chou and colleagues entitled “Emerging Approaches to Diagnosis and Treatment of Non-Muscle-Invasive Bladder Cancer;” however, the key points concerning Cxbladder were covered in the shorter publication and mostly just reiterated in the longer document.

Another systemic review and meta-analysis was published more recently in 2022 by Laukhtina and colleagues.56 The study reviewed five different urinary biomarker tests (UBT) used to detect recurrent urothelial carcinoma, including Cxbladder Monitor. The authors assessed statistical values associated with each test, such as sensitivity, specificity, positive predictive value (PPV), NPV, and accuracy. Additionally, the authors assessed the risk of bias using the Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2), using cystoscopy and histology results for reference. The study also performed network meta-analysis on the tests as compared with cytology. Two Cxbladder Monitor studies were analyzed: Koya (2020) and Lotan (2017).46,50 At the end of the paper, the authors concluded the performances of the five tests “support[ed] their potential value in preventing unnecessary cystoscopies.” The authors also assessed other diagnostic tests from four of the five test companies, including Cxbladder Triage and Detect (O’Sullivan [2012] and Davidson [2019]) and concluded “there are not enough data to support their use in the initial diagnosis setting.”40,52

[psychic]

Specific Lab Tests

Cxbladder (Detect, Triage, Monitor, Resolve)

The fundamental methodology of Cxbladder tests is founded on a 2008 paper from Holyoake and colleagues describing the creation of an RNA expression assay that could predict the likelihood of urothelial carcinoma from urine.39 Several gene expression profiles were examined between urothelial carcinoma tissue and normal urothelial tissue, the latter of which was collected as non-malignant tissue from patients with renal cell carcinoma who had undergone a radical nephrectomy. The gene expression profiles that demonstrated the most promise in differentiating between cancer and non-cancer were gathered into a four gene expression panel and then optimized to discriminate between urine from patients with any grade/stage of urothelial cancer and patients without urothelial cancer. Gene expression tests that are used to predict the presence or absence of cancer, however, must take into consideration many potential complicating and confounding factors. The absence of a rigorous approach to addressing complicating/confounding factors undermined the clinical validity of Cxbladder tests, as will be detailed below.

As evidenced in the publications reviewed in the Summary of Evidence, the key weakness of the Cxbladder tests is found within their test design. Cxbladder tests are founded on the concept that differences in gene expression between urothelial cancer and non-urothelial cancer (including non-neoplastic tissue) can be measured in urine to determine if urothelial cancer is present or not present. This means that a well-designed test will be able to not only discriminate between cancer and normal tissue, but also between different types of malignancy.

For the precursor test uRNA, Holyoake and colleagues started with a custom-printed array from MWG Biotech that allowed gene expression profiling of 26,600 genes.39 This array was used to analyze normal tissue (18 specimens) and urothelial carcinoma tissue (28 specimens from Ta tumors and 30 specimens from T1-T4 tumors). The preliminary data was then analyzed to select the most promising genes for creation of a GEP test. This subset of promising genes was further pruned by testing urine from patients with transitional cell carcinoma (TCC) (urothelial carcinoma) (n=75), patients with other “urological cancer” (n=33), and patients without cancer, including patients with infection (n=20) and “other benign urinary tract disease” (n=24). Additionally, the paper mentions testing blood to get gene expression levels for blood and inflammatory cells, but the results of this subset of tests were not provided in this paper. It must be noted here that the characteristics of the non-TCC cancers were also not disclosed in the paper.

After this additional testing, Holyoake and colleagues settled on four gene expression test (uRNA-D) that utilized the genes MDK, CDC2 (now officially known as CDK1), IGFBP5, and HOXA13.39 Unfortunately, the false positives and false negatives received little attention from the paper, including false positives for patients with other non-TCC cancers (n=3). The authors concluded that their results “will need to be further validated in a prospective setting to more accurately determine test characteristics, particularly in patients presenting with hematuria and other urological conditions.”

Standing alone, the 2008 paper from Holyoake and colleagues lacks the scientific rigor to establish the uRNA-D test as able to accurately distinguish between urothelial carcinoma and other cancers or other non-cancer urological conditions.39 One very notable gap included a lack of details or definition for non-urothelial cancers, of which many would feed into the urinary system, including prostate cancers, renal cancers, and metastatic or locally invasive cancers from other organs. It would be expected that a well-designed test would assess not only the full spectrum of potential cancers, but that the test design would include a much higher count of specimens (beyond the 33 undefined cancers found in this study). In the same sense, the absence of details regarding non-malignant specimens, which included only 20 “urinary tract infections,” was a major and notable gap in this test’s development. There were many other issues identified with this paper including a strong population bias towards male patients, but altogether, this validation of uRNA-D was insufficient to support that the test performed accurately as a tool for distinguishing between urine from patients with and without urothelial carcinoma.

It is critical to understand the limitations of the 2008 publication from Holyoake and colleagues because the test uRNA-D was used to create the Cxbladder line of tests, with the main difference between uRNA-D and Cxbladder being the addition of a single gene, CXCR2, to the gene expression profile of the Cxbladder assay.39,40 It is noted that other versions of Cxbladder use non-genetic data in an overarching algorithm to produce results, but the focus of this discussion will be upon the gene expression profile technology of Cxbladder tests.

In 2012, the first paper describing a Cxbladder test was published by O’Sullivan and colleagues.40 This paper acted as both a test validation and a comparison of the new Cxbladder test with other urine tests on the market. While the statistical results of Cxbladder seem promising, we must return to the foundation of the test, namely its ability to distinguish between urothelial carcinoma and other cancerous or non-cancerous conditions (or patients without disease). In this paper, other malignancies (n=7) were assessed only when they were found in patients with urothelial carcinoma. Moreover, the types of other malignancy were not disclosed in this paper. There are also 255 “nonmalignant disease” specimens, which included representations of “benign prostatic hyperplasia/prostatitis”, “cystitis/infection or inflammation of urinary tract”, calculi, and “hematuria secondary to warfarin,” and 164 specimens from patients with “no specific diagnosis.” This first paper from 2012 also does not sufficiently address Cxbladder’s ability to distinguish between urothelial carcinoma and other malignancies, which is of particular relevance when a majority of the patient population were male (78%) with a median patient age of 64 years and thus, with higher risk of prostate carcinoma. The paucity of clinical data also created gaps in the data integrity, failing to answer questions such as how many of the urothelial carcinoma specimens had coincident inflammation and what other medical conditions (and medications) were present in this patient population? Additionally, the paper does not spend significant time discussing the potential reasons for false positives and false negatives. These issues are compounded by a short follow-up period (only 12-months) with participating patients.

In the most recent paper published for Pacific Edge Diagnostics by Lotan and colleagues in 2022, Cxbladder Triage and Detect were “enhanced” by addition of a different test methodology, digital droplet PCR, adding a different approach to detecting urothelial carcinoma: identification genetic variants associated with urothelial carcinoma.44 This approach was based on the premise that the six variants (called single nucleotide polymorphisms or SNPs in the paper) are either acquired as mutations in the carcinogenesis of urothelial carcinoma or already present as an inherited genetic variant in the patient’s germline DNA, representing a higher risk of urothelial carcinoma. However, it is known that these SNPs can also show up in the context of other malignancies (such as papillary renal cell carcinoma), which is not addressed by Lotan and colleagues.183,184 Moreover, as mentioned in the paper’s discussion, the presence of these SNPs in urine may not coincide with clinically detectable (e.g., cystoscopically visible) carcinoma. This could lead to further confusion with false positives, especially when the PPV of Cxbladder tests tends to be very low. If numerous false positive results in Cxbladder are accepted as an inherent trait of the test, providers may not be as vigilant in closely following patients with a positive Cxbladder result after a negative cystoscopy. In addition, providers may not search for other malignancies (e.g., papillary renal cell carcinoma) as a potential cause for the “false positive” Cxbladder result. Another weakness of the 2022 study was seen in the differences between cohorts. Notably, the six SNPs alone were less sensitive for urothelial carcinoma in the Singapore cohort (66%) than in the United States cohort (83%). This could indicate differences in the genetic etiology of urothelial carcinoma in different populations, meaning that the six SNPs may not be as representative in populations not evaluated in this study. Furthermore, while this study claimed to evaluate multiple ethnicities, the paper does not disclose which ethnicities were evaluated and the numbers of patients from each ethnicity.

Each new Cxbladder test builds on their predecessors, often utilizing the same specimens from prior studies in their test validations and performance characterizations. Moreover, the insufficient assessment of potential confounding factors is perpetuated through these studies. For instance, if we look at assessment of non-urothelial cancer through all major published uDNA and Cxbladder studies, we see the following:

Holyoake 2008: 33 undefined cancers were noted39
O’Sullivan 2012: Seven other malignancies (undefined) were noted, all in patients with urothelial carcinoma40
Kavalieris 2015: Non-urothelial neoplasms were not discussed (study population included 517 patients from the O’Sullivan 2012 study)40,41
Breen 2015: Non-urothelial neoplasms were not discussed (study population included patients from the O’Sullivan 2012 study)40,45
Kavalieris 2017: Non-urothelial neoplasms were not discussed (same patient population as Lotan 2017)42,46
Lotan 2017: Non-urothelial neoplasms were not discussed (same patient population as Kavalieris 2017) 42,46
Konety 2019: In some subpopulations, patients with history of prostate or renal cell carcinoma were excluded from the study; otherwise, non-urothelial neoplasms were not discussed (study population included patients from O’Sullivan 2012 and Kavalieris/Lotan 2017) 40,42,46,49
Davidson 2019: Other non-bladder malignancies and neoplasms were identified (but not subclassified) in a study evaluating hematuria; notably, Cxbladder-Triage was positive in most of these other malignancies (seven of nine total) and neoplasms (two of three total)52
Koya 2020: Non-urothelial neoplasms were not discussed50
Davidson 2020: Other non-bladder malignancies and neoplasms were identified in the study but data was not presented to allow association of these other malignancies and neoplasms with positive or negative results from Cxbladder.53
Raman 2021: In some subpopulations, patients with history of prostate or renal cell carcinoma were excluded from the study; otherwise, non-urothelial neoplasms were not discussed (study population included patients from O’Sullivan 2012 and Konety 2021)40,43,49
Lotan 2022: In some subpopulations, patients with history of prostate or renal cell carcinoma were excluded from the study; otherwise, non-urothelial neoplasms were not discussed44
Li 2023: Some patients (24 of 92 patients) noted to have “other cancers;” except for one mention (a patient with breast cancer who missed their nine month follow-up due to conflict with breast cancer treatment), other types of cancers are not described or significantly discussed51
There are numerous potential malignancies that can contribute to urine genetic composition (e.g., renal cell cancer, bladder cancer, prostate cancer). However, by using only 40 unspecified neoplasm specimens, 33 of which were tested only for uDNA (not Cxbladder), the validation from Pacific Edge Diagnostics underrepresents potentially confounding variables. This underrepresentation is further substantiated through data found in studies not performed or funded by Pacific Edge Diagnostics. In an independent study from Davidson and colleagues in 2019 performed on patients with hematuria, seven of nine malignant prostate or kidney lesions were discovered in patients with a positive Cxbladder-Triage result.52 False positive Cxbladder-Triage results were also seen in a majority of patients without bladder cancer but instead diagnosed with radiation cystitis, vascular prostate, bladder stones, anticoagulation related bleeding, post-TURP bleeding, and urethral stricture. No cause for hematuria was found in 225 patients, with 137 of them having a positive Cxbladder-Triage result. This 2019 study as well as others indicate that Cxbladder is less sensitive for detecting smaller, low grade malignancies making it unlikely the false positives could represent urothelial malignancies below the limit of detection by cystoscopy and other conventional evaluations.52

The exclusion criteria further weakened the development and validation of Cxbladder tests. Consistent with the aforementioned confounding variables of other urinary tract cancers and metastases, the Cxbladder studies generally excluded patients with a history of prostate or renal cancer; however, these exclusions were not always seen in studies funded and/or published by Pacific Edge Diagnostics. The validation studies for Cxbladder also typically excluded inflammatory disorders such as pyelonephritis and active urinary tract infections and also excluded known causes for hematuria like bladder or renal calculi or recent manipulation of the genitourinary tract (e.g., cystoscopy).40-43, 46 In the first published validation study for Cxbladder, the authors stated that the additional 5th RNA marker, CXCR2, “was predicted to reduce the risk of false-positive results in patients with acutely or chronically inflamed urothelium.”40 However, in this same study, the authors went on to exclude patients with “documented urinary tract infection.” Fortunately, publications from other sources such as Davidson and colleagues in 2019 provide insight into how Cxbladder tests (namely Cxbladder Triage) perform under these benign conditions.52 Davidson and colleagues found that false positives were seen in a majority of patients where the underlying etiology of hematuria was radiation cystitis, vascular prostate, bladder stones, anticoagulation related bleeding, post-TURP bleeding, or urethral stricture. False positives were also seen in 10 of 23 (43%) patients with urinary tract infection and 8 of 10 (80%) patients with “other” inflammatory etiologies. Altogether, in the inflammatory category of the study, over half (59%) of patients with an inflammatory etiology of their hematuria received a false positive result from the Cxbladder Triage (CxbT) test. In a subsequent study by Davidson and colleagues in 2020, “approximately 10% of patients (85 of 884) required a repeat CxbT assay because quality control failures, mainly caused by interference of inflammatory products or a large number of white blood cells.”53 The couple of systemic reviews and meta-analyses that included Cxbladder tests were mixed in their assessment of this line of tests. Chou and colleagues in 2015 only reviewed one of the Cxbladder papers (O’Sullivan 2012) and came to the conclusion that the strength of evidence for the study was graded low.40,54,55 In 2022, Laukhtina and colleagues performed a more involved assessment of Cxbladder tests, particularly Cxbladder Monitor, coming to the conclusion that it had “potential value in preventing unnecessary cystoscopies.”56 The authors also determined that there was “not enough data to support” using Cxbladder Triage and Detect in the “initial diagnosis setting.” Laukhtina and colleagues did acknowledge that their study had several potential limitations which included the “absence of data on blinding to pathologist and urologists” and the inability to “perform subgroup analyses for HG [High Grade urothelial carcinoma] recurrence detection only.” However, it should be noted that for both the 2015 and 2022 systemic reviews and meta-analyses, the evaluation of the actual clinical features of each Cxbladder study was relatively superficial, focusing more on the statistical values and less on the quality of the studies and the designs underlying those values.54-56

In conclusion, the Cxbladder line of tests all suffer from the foundational problem of insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry. The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49 These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result. Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test’s parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers. Finally, and most importantly, due to the insufficient representation of confounding factors in the validation populations, the Cxbladder tests have not been adequately vetted in the context of the Medicare population. Given all of these findings, the Cxbladder line of tests are considered not medically reasonable and necessary for Medicare patients.

[JSwan]

What’s the TL;DR of the above?

[Snow Leopard]

What’s the TL;DR of the above?

It is a piss poor test developed using limited dodgy data, not validated properly with short-comings ignored.

If still TL;DR;

It's rubbish.

[psychic]

[QUOTE=JSwan;1014138]WhatÂ’s the TL;DR of the above

In conclusion, the Cxbladder line of tests all suffer from the foundational problem of insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry. The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49 These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result. Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the testÂ’s parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers. Finally, and most importantly, due to the insufficient representation of confounding factors in the validation populations, the Cxbladder tests have not been adequately vetted in the context of the Medicare population. Given all of these findings, the Cxbladder line of tests are considered not medically reasonable and necessary for Medicare patients.

[psychic]

Or, what snowy says haha

[Poverty]

Summary of the Report on Cxbladder Tests:
The report critically evaluates the Cxbladder line of tests, which are designed to detect urothelial carcinoma (bladder cancer) from urine samples. The tests are based on a gene expression panel that aims to differentiate between cancerous and non-cancerous (including non-neoplastic) tissues. The report identifies several weaknesses in the test design, which undermine their clinical validity.



Lack of Scientific Rigor: The foundational 2008 paper by Holyoake and colleagues lacks the scientific rigor needed to establish the uRNA-D test (the precursor of Cxbladder) as an accurate tool for distinguishing between urothelial carcinoma and other types of cancer or non-cancer urological conditions. The test was not adequately assessed against various potential confounding factors, such as different types of cancers and non-malignant conditions.

Insufficient Representation of Confounding Factors: The validation studies for Cxbladder did not adequately consider potential confounding variables, such as other urinary tract cancers and metastases. Some studies excluded patients with a history of prostate or renal cancer, inflammatory disorders, or known causes of hematuria, which may have skewed the test results.

Population Bias: Early papers on Cxbladder had a strong bias towards male patients of European ancestry, which raises concerns about the test's applicability to a broader and more diverse patient population.

Low Positive Predictive Value (PPV) and High False Positive Rate: Cxbladder tests generally have low PPVs, meaning that they often generate false positive results. This can lead to patient anxiety and unnecessary follow-up procedures based on inaccurate results.

Conflict of Interest: Most of the primary literature regarding Cxbladder test development and performance is funded or directly written by Pacific Edge Diagnostics, the parent company of the test. This raises concerns about potential bias in the research.


Inadequate Vetted in the Medicare Population: Due to the insufficient representation of confounding factors in the validation populations, the Cxbladder tests have not been adequately evaluated in the context of the Medicare population.


In conclusion, the report states that the Cxbladder line of tests is not considered medically reasonable and necessary for Medicare patients. It highlights the need for more rigorous and independent validation of the tests to establish their clinical utility and reliability.

[bottomfeeder]

What? Quoting 2008 paper. That was 15 years ago. What is truly alarming, is that I couldn't stay awake reading all the historical blurb. You know if I had a million dollars invested in PEB I would have read this carefully, but I just recently bought back in with 40k shares. With that small amount, I just want to hear one line, pleasant posts.

[carrom74]

What? Quoting 2008 paper. That was 15 years ago. What is truly alarming, is that I couldn't stay awake reading all the historical blurb. You know if I had a million dollars invested in PEB I would have read this carefully, but I just recently bought back in with 40k shares. With that small amount, I just want to hear one line, pleasant posts.

A “pleasant post”… PEB CEO interview. About two months ago..he sounds positive(?)

https://youtu.be/w8FLi6s1Qfk?si=Lrf37D9GbS6RywiD

[bottomfeeder]

A “pleasant post”… PEB CEO interview. About two months ago..he sounds positive(?)

https://youtu.be/w8FLi6s1Qfk?si=Lrf37D9GbS6RywiD

Dismal figures, yet there are always takers for the CR. No way to spin this nicely. Im out tomorrow.

[850man]

Directors buying in https://www.nzx.com/announcements/415747

[sunnysleeper11]

Yep - I noticed that too.
One director spending $1500 in total.
Does this show confidence to shareholders?

[winner69]

Directors buying in https://www.nzx.com/announcements/415747

Gallagher much cheaper than the $1.35 he last bought for

[silverblizzard888]

Gallagher spending $54k on shares thats pretty decent, must have some plans to turn it around. At the same time if they're buying then theres nothing material going on yet, just some master plan or belief.

[X-men]

Gosh..sp at 13c....the market value of PEB is still at $100m ovet

[silverblizzard888]

Gosh..sp at 13c....the market value of PEB is still at $100m ovet

Yeah its a bit high considering there futures a bit uncertain. 9 cent stock at best at the moment

[winner69]

Another Director buying

Good sign because ‘they have confidence in the company’ or just somebody taking a punt and hoping they get lucky

I tend to think it’s just taking a punt

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/415927/399886.pdf

[silverblizzard888]

Another Director buying

Good sign because ‘they have confidence in the company’ or just somebody taking a punt and hoping they get lucky

I tend to think it’s just taking a punt

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/415927/399886.pdf

Well it can't be based on any material information on upcoming decisions or they'd be in trouble, so very much a punt on confidence that they can turn it around, but good sign Chairman ($54k), CFO ($1.5k) and Director ($50k) are buying. However CEO is not buying.

[Sideshow Bob]

Blackrock.....although they made about 9 disclosures this morning for various companies.....

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/416083/400070.pdf

[Sampan]

Any idea what Blackrock doing here ?? Surely they havent bought that many....

[GTM 3442]

Blackrock sure seem to have decided to splash some cash into New Zealand.

GMT, PEB, OCA PFI, CEN so far this morning. What gives?

[Sampan]

All of those names do make some sense....all except one of them...!

[Sampan]

To: Market Participants
From: NZX Product Operations
Date: Thursday, 10 August 2023
Subject: NZXO – Announcement Retractions
Message:
NZX Product Operations (“NZXO”) wishes to advise that the announcements titled “SPH Notice - BlackRock, Inc. and related bodies corporate” released under the following tickers, have been retracted at the request of BlackRock:
- “GMT” - Goodman Property Trust at 8:43am
- “VHP” - Vital Healthcare Property Trust at 8:57am
- “OCA” – Oceania Healthcare Limited at 9:02am
- “SUM” – Summerset Group Holdings Limited at 9:16am
- “SPG” – Stride Property Ltd & Stride Investment Management Ltd at 9:20am
- “ATM” – The a2 Milk Company Limited at 9:22am
- “PFI” – Property for Industry Limited 9:28am
- “PEB” – Pacific Edge Limited at 9:57am
- “AIA” – Auckland International Airport Limited at 10:05am
- “CEN” – Contact Energy Limited at 10:07am
- “RYM” – Ryman Healthcare Limited at 10:19am
ENDS

[silu]

Blackrock so embarrassed they don't want the market to know that they hold shares?

[carrom74]

Well.. the risk is real!

https://www.reuters.com/business/healthcare-pharmaceuticals/fda-rejects-mesoblasts-cell-therapy-bone-marrow-transplant-complications-2023-08-04/

[whatsup]

Are we heading to sub .11 ?

[Pegasus2000]

wrong thread - removed. apology.

[ronaldson]

IKE wins Subscription Contract for expected $1.5m+
IKE
28/08/2023 08:31
MKTUPDTE
PRICE SENSITIVE
REL: 0831 HRS ikeGPS Group Limited

MKTUPDTE: IKE: IKE wins Subscription Contract for expected $1.5m+

IKE wins Subscription Contract for expected $1.5m+

Supporting a Customer that is Assessing more than One Million Distribution
Assets

ikeGPS Group Limited (ASX/NZX:IKE) or IKE, today announces:

? That it has signed a new subscription contract with a large U.S.-wide
infrastructure customer, in this instance supporting a network assessment in
California.
? This customer contract is expected to generate approximately $1.5m or
greater of subscription revenue in the coming 18 to 24 months.
? This is a contract extension following an initial proof of concept
deployment.
? This customer is utilizing the IKE software platform to speed the
engineering assessment of ultimately more than one million distribution
network pole assets.

IKE CEO Glenn Milnes commented, "The growth across this infrastructure
customer further demonstrates the value that the IKE platform provides to
communications companies and electric utilities, and our ability to expand
the use of our platform over time across customers. The initial contract with
this customer is large, however there are opportunities to deliver
significantly more IKE capability into this group over time. This customer
also represents the new and large market opportunity for IKE in California,
with recent regulatory requirements requiring all pole owners to perform a
full engineering assessment of their networks. IKE products dramatically
increase the speed, quality, and safety for the construction and maintenance
of distribution assets. Our broader in-market momentum with existing
customers and targets gives us a high degree of confidence for strong
long-term growth."

ENDS


Why on the PEB thread?

[winner69]

Why on the PEB thread?

Maybe saying IKE a better bet than PEB

[BigBob]

US Urological Societies Call for Medicare LCD Revision

Dear Shareholder,

Pacific Edge welcomes the strong industry and clinician support it has received during the open public meetings to take feedback on draft local coverage determinations (LCDs) that propose non-coverage of Cxbladder tests by Medicare, the US national health insurance provider.

At the meetings - hosted earlier this month by the Medicare Administrative Contractors (MACs) Novitas and First Coast Service Operations (FCSO) - the American Urological Association (AUA), the Large Urology Group Practice Association (LUGPA), and the American Association of Clinical Urologists (AACU) - the three most influential urological organisations, covering every practicing urologist in the USA - joined with the Coalition for 21st Century Medicine (C21), the American Clinical Laboratory Association (ACLA), and Pacific Edge to call for significant revisions to the draft determinations and continued Medicare coverage of Cxbladder.

Pacific Edge Chief Executive Dr Peter Meintjes said: “We are delighted with the way the urological community has quickly educated themselves on the ramifications of the draft LCDs and rallied for Cxbladder and other similar biomarkers to remain covered so providing benefits for Medicare patients.

“Leading clinicians representing the three largest professional societies and our industry partners share our view that the high negative predictive value of Cxbladder offers significant clinical utility to Medicare patients in the context of the standard of care in urology and that it has been repeatedly validated for this purpose in peer-reviewed publications,” Dr Meintjes said.

Novitas the MAC with jurisdiction for Pacific Edge’s US laboratory, held a hearing on the Draft LCD ‘Genetic testing for oncology’ (DL39365) on August 112 while, Novitas sister MAC FCSO, held a hearing on August 10 for an identical draft LCD with the same title but with a different code (DL39367) to cover test providers in its area of jurisdiction. Both draft LCD’s argue Cxbladder is not medically reasonable or necessary and therefore not eligible for coverage under the US Social Security Act.

In their joint presentations to Novitas and FCSO, the AUA, LUGPA, and the AACU noted Cxbladder and another urine tumor marker, UroVysion, play a crucial role in the diagnosis, management and surveillance of bladder cancer. Representatives of the organisations said the tests were for evaluation of hematuria patients and not ‘genetic tests for cancer’ so were beyond the scope of the draft LCDs, which have been worded to require a cancer diagnosis or substantiated suspicion of cancer. They argued the LCDs determination to outsource coverage to three external databases3 was flawed and said the determinations ignored the clinical utility of the tests.

They also noted the draft non-coverage decisions by Novitas and FCSO:

conflicted with AUA guidelines;
were not supported by the clinical evidence they used to justify the draft decision;
could lead to worse patient outcomes and higher costs; and
could exacerbate existing disparities in bladder cancer care.


The presentations are available on Pacific Edge’s website at the following link:
https://www.pacificedgedx.com/investors/presentations/

The meetings were held in line with the statutory requirement for MACs to give a 45-day notice and comment period commencing 27 July 20232 and finishing 9 September 20232, during which time all interested stakeholders may submit comments to Novitas. Pacific Edge expects all of the groups that participated in the open public meetings, plus numerous individual urological key opinion leaders (KOLs) and groups of KOLs to submit written feedback through this process prior to 9 September 2023.

While the Open Public Meetings are an important part of the process, the written submissions are ultimately the most crucial, as MACs are required to respond to all comments in a process that is also reviewed by the Centers for Medicare and Medicaid Services (CMS).

Novitas and FCSO may take up to 365 days from the original publication date (27 July 20232) to withdraw or finalize the LCD including a response to those comments. When finalized, the MACs must provide a minimum of 45 days’ notice before the LCD becomes effective.

1 PEB has not released the information contained in this update to the NZX and ASX as it does not regard it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act.
2 US time.
3 The draft LCDs outsources coverage decisions to three knowledge bases to determine coverage, rather than the MAC. They are Clinical Genome Resource (ClinGen); National Comprehensive Cancer Network (NCCN); Oncology Knowledge Base (OncoKB) knowledge bases.

[whatsup]

US Urological Societies Call for Medicare LCD Revision

Dear Shareholder,

Pacific Edge welcomes the strong industry and clinician support it has received during the open public meetings to take feedback on draft local coverage determinations (LCDs) that propose non-coverage of Cxbladder tests by Medicare, the US national health insurance provider.

At the meetings - hosted earlier this month by the Medicare Administrative Contractors (MACs) Novitas and First Coast Service Operations (FCSO) - the American Urological Association (AUA), the Large Urology Group Practice Association (LUGPA), and the American Association of Clinical Urologists (AACU) - the three most influential urological organisations, covering every practicing urologist in the USA - joined with the Coalition for 21st Century Medicine (C21), the American Clinical Laboratory Association (ACLA), and Pacific Edge to call for significant revisions to the draft determinations and continued Medicare coverage of Cxbladder.

Pacific Edge Chief Executive Dr Peter Meintjes said: “We are delighted with the way the urological community has quickly educated themselves on the ramifications of the draft LCDs and rallied for Cxbladder and other similar biomarkers to remain covered so providing benefits for Medicare patients.

“Leading clinicians representing the three largest professional societies and our industry partners share our view that the high negative predictive value of Cxbladder offers significant clinical utility to Medicare patients in the context of the standard of care in urology and that it has been repeatedly validated for this purpose in peer-reviewed publications,” Dr Meintjes said.

Novitas the MAC with jurisdiction for Pacific Edge’s US laboratory, held a hearing on the Draft LCD ‘Genetic testing for oncology’ (DL39365) on August 112 while, Novitas sister MAC FCSO, held a hearing on August 10 for an identical draft LCD with the same title but with a different code (DL39367) to cover test providers in its area of jurisdiction. Both draft LCD’s argue Cxbladder is not medically reasonable or necessary and therefore not eligible for coverage under the US Social Security Act.

In their joint presentations to Novitas and FCSO, the AUA, LUGPA, and the AACU noted Cxbladder and another urine tumor marker, UroVysion, play a crucial role in the diagnosis, management and surveillance of bladder cancer. Representatives of the organisations said the tests were for evaluation of hematuria patients and not ‘genetic tests for cancer’ so were beyond the scope of the draft LCDs, which have been worded to require a cancer diagnosis or substantiated suspicion of cancer. They argued the LCDs determination to outsource coverage to three external databases3 was flawed and said the determinations ignored the clinical utility of the tests.

They also noted the draft non-coverage decisions by Novitas and FCSO:

conflicted with AUA guidelines;
were not supported by the clinical evidence they used to justify the draft decision;
could lead to worse patient outcomes and higher costs; and
could exacerbate existing disparities in bladder cancer care.


The presentations are available on Pacific Edge’s website at the following link:
https://www.pacificedgedx.com/investors/presentations/

The meetings were held in line with the statutory requirement for MACs to give a 45-day notice and comment period commencing 27 July 20232 and finishing 9 September 20232, during which time all interested stakeholders may submit comments to Novitas. Pacific Edge expects all of the groups that participated in the open public meetings, plus numerous individual urological key opinion leaders (KOLs) and groups of KOLs to submit written feedback through this process prior to 9 September 2023.

While the Open Public Meetings are an important part of the process, the written submissions are ultimately the most crucial, as MACs are required to respond to all comments in a process that is also reviewed by the Centers for Medicare and Medicaid Services (CMS).

Novitas and FCSO may take up to 365 days from the original publication date (27 July 20232) to withdraw or finalize the LCD including a response to those comments. When finalized, the MACs must provide a minimum of 45 days’ notice before the LCD becomes effective.

1 PEB has not released the information contained in this update to the NZX and ASX as it does not regard it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act.
2 US time.
3 The draft LCDs outsources coverage decisions to three knowledge bases to determine coverage, rather than the MAC. They are Clinical Genome Resource (ClinGen); National Comprehensive Cancer Network (NCCN); Oncology Knowledge Base (OncoKB) knowledge bases.

Why isnt this posted on the NZX web page ?

[BigBob]

Why isnt this posted on the NZX web page ?

As per above footnote:

"1 PEB has not released the information contained in this update to the NZX and ASX as it does not regard it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act."

They've done that a few times...

[whatsup]

US Urological Societies Call for Medicare LCD Revision

Dear Shareholder,

Pacific Edge welcomes the strong industry and clinician support it has received during the open public meetings to take feedback on draft local coverage determinations (LCDs) that propose non-coverage of Cxbladder tests by Medicare, the US national health insurance provider.

At the meetings - hosted earlier this month by the Medicare Administrative Contractors (MACs) Novitas and First Coast Service Operations (FCSO) - the American Urological Association (AUA), the Large Urology Group Practice Association (LUGPA), and the American Association of Clinical Urologists (AACU) - the three most influential urological organisations, covering every practicing urologist in the USA - joined with the Coalition for 21st Century Medicine (C21), the American Clinical Laboratory Association (ACLA), and Pacific Edge to call for significant revisions to the draft determinations and continued Medicare coverage of Cxbladder.

Pacific Edge Chief Executive Dr Peter Meintjes said: “We are delighted with the way the urological community has quickly educated themselves on the ramifications of the draft LCDs and rallied for Cxbladder and other similar biomarkers to remain covered so providing benefits for Medicare patients.

“Leading clinicians representing the three largest professional societies and our industry partners share our view that the high negative predictive value of Cxbladder offers significant clinical utility to Medicare patients in the context of the standard of care in urology and that it has been repeatedly validated for this purpose in peer-reviewed publications,” Dr Meintjes said.

Novitas the MAC with jurisdiction for Pacific Edge’s US laboratory, held a hearing on the Draft LCD ‘Genetic testing for oncology’ (DL39365) on August 112 while, Novitas sister MAC FCSO, held a hearing on August 10 for an identical draft LCD with the same title but with a different code (DL39367) to cover test providers in its area of jurisdiction. Both draft LCD’s argue Cxbladder is not medically reasonable or necessary and therefore not eligible for coverage under the US Social Security Act.

In their joint presentations to Novitas and FCSO, the AUA, LUGPA, and the AACU noted Cxbladder and another urine tumor marker, UroVysion, play a crucial role in the diagnosis, management and surveillance of bladder cancer. Representatives of the organisations said the tests were for evaluation of hematuria patients and not ‘genetic tests for cancer’ so were beyond the scope of the draft LCDs, which have been worded to require a cancer diagnosis or substantiated suspicion of cancer. They argued the LCDs determination to outsource coverage to three external databases3 was flawed and said the determinations ignored the clinical utility of the tests.

They also noted the draft non-coverage decisions by Novitas and FCSO:

conflicted with AUA guidelines;
were not supported by the clinical evidence they used to justify the draft decision;
could lead to worse patient outcomes and higher costs; and
could exacerbate existing disparities in bladder cancer care.


The presentations are available on Pacific Edge’s website at the following link:
https://www.pacificedgedx.com/investors/presentations/

The meetings were held in line with the statutory requirement for MACs to give a 45-day notice and comment period commencing 27 July 20232 and finishing 9 September 20232, during which time all interested stakeholders may submit comments to Novitas. Pacific Edge expects all of the groups that participated in the open public meetings, plus numerous individual urological key opinion leaders (KOLs) and groups of KOLs to submit written feedback through this process prior to 9 September 2023.

While the Open Public Meetings are an important part of the process, the written submissions are ultimately the most crucial, as MACs are required to respond to all comments in a process that is also reviewed by the Centers for Medicare and Medicaid Services (CMS).

Novitas and FCSO may take up to 365 days from the original publication date (27 July 20232) to withdraw or finalize the LCD including a response to those comments. When finalized, the MACs must provide a minimum of 45 days’ notice before the LCD becomes effective.

1 PEB has not released the information contained in this update to the NZX and ASX as it does not regard it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act.
2 US time.
3 The draft LCDs outsources coverage decisions to three knowledge bases to determine coverage, rather than the MAC. They are Clinical Genome Resource (ClinGen); National Comprehensive Cancer Network (NCCN); Oncology Knowledge Base (OncoKB) knowledge bases.

PEB up 10% today , wonder if the market has a favourable interperation of this article, looks like it to me from the reaction so far today.

[kiora]

They are not alone
https://www.medscape.com/viewarticle/995950?ecd=wnl_recnlnew5_ous_230831_MSCPEDIT_etid5 806438&uac=426896AZ&impID=5806438

[whatsup]

Getting smashed today- again !

[whatsup]

Whats going on with PEB today ?, knocking on .11's door !

[whatsup]

and up over 5% so far today, whatsup ?

[whatsup]

On the move again today up another 8% so far .

[winner69]

On the move again today up another 8% so far .

Seems you the only cheerleader left whatsup ….good you keeping the faith

[whatsup]

Seems you the only cheerleader left whatsup ….good you keeping the faith

They are free carry for me, traded since 2017 plus a good profit !!

Hope springs eternal.

[850man]

Over 20 million shares set to trade end of day today, wonder what's going on?

[Greekwatchdog]

Over 20 million shares set to trade end of day today, wonder what's going on?

Index rebalancing

[fulliautomateix]

Over 20 million shares set to trade end of day today, wonder what's going on?

So I guess the question is how do you know its just Index Rebalancing

[clip]

Saw posted on hotcopper today is a triple witching day, may be related. Don't know if relevant to NZ at all though, appears to be a US thing

What Is Triple Witching?

Triple witching is the simultaneous expiration of stock options, stock index futures, and stock index options contracts all on the same trading day. This happens four times a year: on the third Friday of March, June, September, and December. A common expiration date for the three types of equities derivatives can cause increased trading volume and unusual price action in the underlying assets.

[whatsup]

Why is there an announcement ( not price sensitive ) in Aust and not here in N Z , looks like the major holders are buying, Masfen & others ?

[whatsup]

Why is there an announcement ( not price sensitive ) in Aust and not here in N Z , looks like the major holders are buying, Masfen & others ?

Just been posted but way behind ASX !!

[850man]

Was posted on the NSX just now. Anatole Masfen just stumped up over $1M for 8M shares http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/418488/403280.pdf (http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/418488/403280.pdf)

[Greekwatchdog]

This was posted at 2.29pm on NZX, 2.36pm on ASX

[850man]

Was posted on the NSX just now. Anatole Masfen just stumped up over $1M for 8M shares http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/418488/403280.pdf (http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/418488/403280.pdf)

The last lot he bought cost him $1.7M and was at $1.35 each! He's now got over 9.3M of them at average cost of 30c each.

[JSwan]

The last lot he bought cost him $1.7M and was at $1.35 each! He's now got over 9.3M of them at average cost of 30c each.

Dang, so share price needs to go to 30c for him to break even

[850man]

Article published yesterday entitled "Molecular Markers for Bladder Cancer Screening: An Insight into Bladder Cancer and FDA-Approved Biomarkers" https://www.mdpi.com/1422-0067/24/18/14374

[carrom74]

Article published yesterday entitled "Molecular Markers for Bladder Cancer Screening: An Insight into Bladder Cancer and FDA-Approved Biomarkers" https://www.mdpi.com/1422-0067/24/18/14374
Thanks for sharing. I find this bit of the report quite encouraging.

“Numerous tests have been conducted to identify mRNA biomarkers and multi-gene panels. Among these, we are going to mention a few: CxBladder has undergone extensive examination, with different variations serving distinct purposes: Cxbladder® Detect is employed to detect bladder cancer in hematuria patients, demonstrating sensitivity of 82% and specificity of 85% [150]. Cxbladder® Triage is used for hematuria patients to rule out bladder cancer, achieving a negative predictive value of 97% and sensitivity of 95% [151]. Cxbladder® Monitor serves as a complement to surveillance and has been compared with urine cytology, NMP22 BladderChek, and NMP22 ELISA. It exhibits significantly higher sensitivity and specificity of 91/96 compared to 22/87%, 11/87%, and 26/86%, respectively [152]. CxBladder Monitor (CxBM) was incorporated into local guidelines, where low-risk patients alternated between annual CxBM and cystoscopy thereafter [153]. Their findings showed that 77.8% of patients could safely manage with just one cystoscopy every 2 years, leading to a 39% reduction in the total number of annual cystoscopies. This practical advantage of CxBM in clinical practice has contributed to its increased utilization”

[850man]

Thanks for sharing. I find this bit of the report quite encouraging.

“Numerous tests have been conducted to identify mRNA biomarkers and multi-gene panels. Among these, we are going to mention a few: CxBladder has undergone extensive examination, with different variations serving distinct purposes: Cxbladder® Detect is employed to detect bladder cancer in hematuria patients, demonstrating sensitivity of 82% and specificity of 85% [150]. Cxbladder® Triage is used for hematuria patients to rule out bladder cancer, achieving a negative predictive value of 97% and sensitivity of 95% [151]. Cxbladder® Monitor serves as a complement to surveillance and has been compared with urine cytology, NMP22 BladderChek, and NMP22 ELISA. It exhibits significantly higher sensitivity and specificity of 91/96 compared to 22/87%, 11/87%, and 26/86%, respectively [152]. CxBladder Monitor (CxBM) was incorporated into local guidelines, where low-risk patients alternated between annual CxBM and cystoscopy thereafter [153]. Their findings showed that 77.8% of patients could safely manage with just one cystoscopy every 2 years, leading to a 39% reduction in the total number of annual cystoscopies. This practical advantage of CxBM in clinical practice has contributed to its increased utilization”

Yes, CXBladder is seen by urologists as a key part of the diagnosis of haematuria, based on the AUA feedback to Novitas' proposed LCD. http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/417969/402704.pdf

[winner69]

Lots of long words and doesn’t make much sense to me but I suppose it’s not bad news even though market PRICE SENSITIVE

Word regulate in heading a bit of a worry though

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/419211/404203.pdf

[Roskat]

Lots of long words and doesn’t make much sense to me but I suppose it’s not bad news even though market PRICE SENSITIVE

Word regulate in heading a bit of a worry though

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/419211/404203.pdf
Some extra info winner. FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests




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For Immediate Release:September 29, 2023
Today, the U.S. Food and Drug Administration announced a proposed rule regarding laboratory developed tests, or LDTs, which play an important role in healthcare. The rule is aimed at helping to ensure the safety and effectiveness of these tests, which are used in a growing number of health care decisions and for which concerns have been raised for many years.
LDTs are in vitro diagnostic products (IVDs) that the FDA has described as intended for clinical use and designed, manufactured and used within a single clinical laboratory which meets certain laboratory requirements. IVDs are intended for use in the collection, preparation and examination of specimens taken from the human body, such as blood, saliva or tissue. IVDs, including LDTs, can be used to measure or detect substances, analytes or markers in the body, such as proteins, glucose, cholesterol or DNA, to provide information about a patient’s health, including to diagnose, monitor or determine treatment for diseases and conditions.
The proposed rule seeks to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA is proposing a policy under which the agency intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach to LDTs.
Although historically the FDA has generally exercised enforcement discretion over most LDTs, meaning that the agency generally has not enforced applicable requirements with respect to most LDTs, the risks associated with most modern LDTs are much greater than the risks that were associated with LDTs used decades ago. The agency has become increasingly concerned that some LDTs may not provide accurate test results or perform as well as FDA-authorized tests and others complying with FDA requirements. Recent information, including evidence from a variety of sources, including published studies in scientific literature, allegations of problematic tests reported to the FDA, the agency’s own experience (https://www.nejm.org/doi/full/10.1056/NEJMp2023830)External Link Disclaimer (http://www.fda.gov/about-fda/website-policies/website-disclaimer) in reviewing IVDs offered as LDTs, news articles and class-action lawsuits suggest that the situation is getting worse.
The FDA is concerned patients could initiate unnecessary treatment, or delay or forego proper treatment altogether, based on inaccurate test results, which could result in harm, including worsening illness or death. For example, the FDA is aware of IVDs offered as LDTs that could have led to: patients being over- or under-treated for heart disease; patients with cancer being exposed to inappropriate therapies or not getting effective therapies; and incorrect diagnoses of rare diseases, autism, and Alzheimer’s Disease.
“A growing number of clinical diagnostic tests are being offered as laboratory developed tests without assurance that they work. The stakes are getting higher as these tests are increasingly being used to drive treatment decisions,” said FDA Commissioner Robert M. Califf, M.D. “According to the Centers for Disease Control and Prevention, 70% of today’s medical decisions depend on laboratory test results. Given the role these tests play in modern medical care, their accuracy and validity have a significant impact on public health.”
In the 1970s and 1980s, many LDTs were lower risk, small volume and used for specialized needs of a local patient population. Since then, due to changes in business practices and increasing ability to ship patient specimens across the country quickly, many LDTs are now used more widely, for a larger and more diverse population, with large laboratories accepting specimens from across the country. LDTs are also increasingly relying on high-tech instrumentation and software, being performed in large volumes and being used more frequently to help guide critical health care decisions.
“Through increased FDA oversight, the public, including patients and health care professionals, should have confidence that the tests they rely on are accurate,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “It is important that these tests be held to the same standards as other tests, while helping to ensure test makers have the flexibilities they need to continue innovating and developing tests critical to the advancement of public health.”
Under the approach described in the notice of proposed rulemaking, the FDA would phase out its general enforcement discretion approach for most LDTs. The proposed phaseout is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while avoiding undue disruption to the testing market. After this phaseout, the FDA generally would expect IVD makers to meet the same applicable requirements, except where meeting certain requirements under the Clinical Laboratory Improvement Amendments can be leveraged.
The FDA believes this proposal would also advance responsible innovation by both laboratory and non-laboratory IVD manufacturers alike by better assuring the safety and effectiveness of IVDs offered as LDTs and removing a disincentive for non-laboratory manufacturers to develop novel tests. The current approach disincentivizes innovation by non-laboratory manufacturers who meet FDA requirements and who compete with laboratory manufacturers who do not meet FDA requirements. Rectifying the current imbalance in oversight may foster innovation by manufacturers who are positioned to make safe and effective novel tests available to many labs.
In this proposed rule, the FDA also discusses alternative enforcement approaches for some IVDs offered as LDTs. To the extent commenters support or oppose these alternative approaches, the FDA is requesting a public health rationale, supporting evidence and other information to help inform FDA’s decision-making. Such different approaches include, among others: a different approach for academic medical center laboratories, the continuation of the current general enforcement discretion approach with respect to premarket review and quality system requirements for some or all currently marketed LDTs (i.e., what some previously referred to as “grandfathering”), a phaseout period tailored for small laboratories, and leveraging programs such as the New York State Department of Health Clinical Laboratory Evaluation Program or those within the Veterans Health Administration, as appropriate. Additionally, the FDA would facilitate increased use of the agency’s Third Party Review program (https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/510k-third-party-review-program).
The agency’s economic analysis shows that the benefits would outweigh the costs of the rule. The FDA anticipates the benefits of phasing out the FDA’s general enforcement discretion approach for LDTs would include a reduction in healthcare costs associated with unsafe or ineffective tests, including tests promoted with false or misleading claims and from therapeutic decisions based on the results of those tests.
The FDA believes all patients deserve to have access to safe and effective tests regardless of where those tests are made. This rule is an important step to help ensure that healthcare decisions are made based on test results patients can trust.
Related Information



Federal Register, Notice of Proposed Rulemaking (https://www.federalregister.gov/public-inspection/2023-21662/medical-devices-laboratory-developed-tests)
FDA: Laboratory Developed Tests (https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests)

[mr optimistic]

I'm sorry but anyone with a little common sense, would have realised that eventually this type of test would need to be registered as an FDA approved medical device. That should have been their focus from day 1. All this other BS they've going through is as heavily regulated as registering as a medical device. There are no shortcuts. They've been dancing around this for years.....

[850man]

Looking at the many words, seems everything falls into 2 categories - is it safe? Well yes, it's just weeping into a jar. It it effective? PEB have spent the last 20 years proving that.

[Cabinet]

Looking at the many words, seems everything falls into 2 categories - is it safe? Well yes, it's just weeping into a jar. It it effective? PEB have spent the last 20 years proving that.

I regularly feel like weeping with PEB:)

[Walter]

I'm sorry but anyone with a little common sense, would have realised that eventually this type of test would need to be registered as an FDA approved medical device. That should have been their focus from day 1. All this other BS they've going through is as heavily regulated as registering as a medical device. There are no shortcuts. They've been dancing around this for years.....
It's a turf war between regulators FDS vs CLIA
In general terms, the CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health.

[mr optimistic]

Haha. FDA is supreme rule. Not only in the US but globally. The clear opportunity for PEB is get through all this BS and get people using it. It will never replace the more invasive test to confirm the cancer exists, but the easy opportunity is as a post treatment test once a baseline is confirmed. Unfortunately the demographics of most bladder cancer patients isnt great. Chances are they havent lived a very healthy life and following the simple rules of peeing in a jar and sending it back to the lab are not high. But, it is still a big opportunity to own this process. The disruptive replacement of the current extremely expensive invasive diagnostic go to market plan failed, time to re-think. Dave Darling was good at raising cash, but his ego got in the way of thinking laterally.

[Roskat]

Novitas Publishes Transcript for 8/11 Onco LCD Open Meeting; I Summarize All 21 Speeches (https://p.feedblitz.com/t3/1128310/208112090/13479785_/~feeds.feedblitz.com/~/798021107/0/discoveriesinhealthpolicy~Novitas-Publishes-Transcript-for-Onco-LCD-Open-Meeting-I-Summarize-All-Speeches.html)




https://blogger.googleusercontent.com/img/a/AVvXsEgneCxuH3g5jUpg8B2VQ-LuMdtTrNSvIre4mGJe1iVTgEm5HjhBcD_jeYl1I5jjeeYf0YgW C7kDmpSOtPjDWj0fOh3BDj5VUfL4uH33Z0Ho_RuyxvQ14miJD3 gU-c46VN3nCJX30-5KDvyjyZ2iI6seRS3szxoOogLQowaNX8J-BPIzCJ4CkS_ppxf22bE=s72-c (https://p.feedblitz.com/t3/1128310/208112090/13479785_/~feeds.feedblitz.com/~/798021107/0/discoveriesinhealthpolicy~Novitas-Publishes-Transcript-for-Onco-LCD-Open-Meeting-I-Summarize-All-Speeches.html)




Much ink has been spilled, from here to Genomeweb and elsewhere, about a literally massive (and confusing) new LCD and billing article that Novitas is attempting to roll out for oncology-related tests.A 44-signature public comment letter by ACLA and others has been released.NEW NEWS: HUGE TRANSCRIPT PUBLISHEDThey've posted the transcript of the August 11, 2023 public comment meeting

9 PACIFIC EDGE SHOSKES
Dr. Daniel Shoskes, Senior Medical Director at Pacific Edge Diagnostics, discussed the Local Coverage Determination (LCD) for diagnostic laboratory tests, specifically focusing on the Cxbladder family of tests. He emphasized the importance of correctly characterizing these tests, their purpose, and their role in evaluating and managing hematuria and non-muscle invasive bladder cancer.

Dr. Shoskes explained that the Cxbladder Triage and Detect tests are designed to address the need for cystoscopy in patients with hematuria. Since a vast majority of patients undergoing cystoscopy do not have bladder cancer, these genomic tests are intended to have a high negative predictive value and rule out patients at low risk of urothelial cancer. This approach can significantly reduce unnecessary cystoscopies, resulting in fewer complications, cost savings, and less environmental impact.
He clarified that Cxbladder is not intended to identify other types of cancer, as its sole purpose is to rule out bladder cancer, which is the focus of the AUA guidelines for hematuria workup.
Dr. Shoskes responded to criticisms in the LCD, addressing issues related to false positives, company funding, the inclusion of tests in development, the male bias in study populations, and the need for long-term follow-up. He argued that Cxbladder tests serve their intended purpose effectively and that company sponsorship is a standard practice in the industry.
In conclusion, Dr. Shoskes recommended that Cxbladder Triage and Detect be removed from the scope of the LCD, that Cxbladder Monitor retains coverage due to its utility in the Medicare population, and that references to tests not commercially available be removed from the LCD. He emphasized that restricting access to these tests could lead to more unnecessary cystoscopy procedures, increased patient morbidity, higher costs, and wasted resources, without benefiting patients.

[Roskat]

AUA RUBENSTEIN
Dr. Jonathan Rubenstein, representing the American Urological Association (AUA), the Large Urology Group Practice Association, and The American Association of Clinical Urologists, expressed concerns regarding the proposed Local Coverage Determination (LCD) for certain diagnostic laboratory tests. He highlighted that this LCD encompasses urine markers used in the diagnosis and management of bladder cancer and discussed why these markers should be excluded from the scope of this LCD.

Dr. Rubenstein emphasized the importance of urine tumor markers in diagnosing and managing bladder cancer, citing their crucial role in screening, identifying tumors, predicting recurrence, and monitoring treatment responses. He mentioned that these markers are incorporated into screening guidelines and management strategies.
He expressed concerns that urine markers for bladder cancer, such as UroVysion and CxBladder, are not genetic tests within the scope of the LCD, as they function more like stains or immunohistochemistry rather than DNA or RNA-based tests. He argued that their clinical utility and long-standing use in clinical practice should exempt them from the LCD or be considered separately.
Dr. Rubenstein highlighted that the proposed LCD could lead to worse patient outcomes, increased costs, and conflicts with AUA guidelines, potentially exacerbating disparities in bladder cancer care. He also pointed out that restricting coverage for these markers might impact patient access and outcomes, particularly in regions with limited access to urologists.
In conclusion, Dr. Rubenstein urged Novitas to reconsider covering urine tumor markers, emphasizing their importance in managing bladder cancer effectively and efficiently. He recommended either excluding these markers from the LCD or using prior LCD guidance to determine appropriate coverage criteria, including expert input and stakeholder involvement.

[Mel]

AUA RUBENSTEIN
Dr. Jonathan Rubenstein, representing the American Urological Association (AUA), the Large Urology Group Practice Association, and The American Association of Clinical Urologists, expressed concerns regarding the proposed Local Coverage Determination (LCD) for certain diagnostic laboratory tests. He highlighted that this LCD encompasses urine markers used in the diagnosis and management of bladder cancer and discussed why these markers should be excluded from the scope of this LCD.

Dr. Rubenstein emphasized the importance of urine tumor markers in diagnosing and managing bladder cancer, citing their crucial role in screening, identifying tumors, predicting recurrence, and monitoring treatment responses. He mentioned that these markers are incorporated into screening guidelines and management strategies.
He expressed concerns that urine markers for bladder cancer, such as UroVysion and CxBladder, are not genetic tests within the scope of the LCD, as they function more like stains or immunohistochemistry rather than DNA or RNA-based tests. He argued that their clinical utility and long-standing use in clinical practice should exempt them from the LCD or be considered separately.
Dr. Rubenstein highlighted that the proposed LCD could lead to worse patient outcomes, increased costs, and conflicts with AUA guidelines, potentially exacerbating disparities in bladder cancer care. He also pointed out that restricting coverage for these markers might impact patient access and outcomes, particularly in regions with limited access to urologists.
In conclusion, Dr. Rubenstein urged Novitas to reconsider covering urine tumor markers, emphasizing their importance in managing bladder cancer effectively and efficiently. He recommended either excluding these markers from the LCD or using prior LCD guidance to determine appropriate coverage criteria, including expert input and stakeholder involvement.
Thanks for these posts, it illustrates the perspective that PEB is taking on the issue of the coverage determination - the conclusion by Novita is difficult to call IMHO.

[Sideshow Bob]

https://www.nzx.com/announcements/419755

11/10/2023, 9:23 amGENERALQ4 24 - CXBLADDER TEST VOLUMES RESILIENT IN THE FACE OF HEADWINDS

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) announces test volumes processed at its laboratories in the second quarter of the 2024 financial year (Q2 24) fell 12% to 8,525 from 9,704 in the prior quarter (Q1 24) amid the reorganization of our US operations and publicity on the Medicare coverage determinations.

However, the volume of tests processed in Q2 24 represents an 8% increase on the 7,864 tests processed in the same quarter of the prior year (Q2 23). The reorganization, detailed in the company’s Q1 24 investor update also released today, weighed on sales activity in August and early September.

Meanwhile, volumes were also impacted by some uncertainty among physicians and healthcare providers over Cxbladder’s coverage status following the Medicare non-coverage determination in June by Novitas and then its July withdrawal. These effects were exacerbated by the normal July holiday season lull.

Tests processed in our US laboratory were 7,335 tests in Q2 24, a 15% decrease on the 8,627 tests in Q1 24. The figure represents a 9% increase on the 6,699 tests processed in Q2 23. The number of unique ordering clinicians in the US fell 7% through the quarter to 1,147 but is up 17.3% on the 978 clinicians who ordered tests in Q2 23.

Asia Pacific volumes in Q2 24 were 1,190 up 10% on the 1,077 tests processed in Q1 24, and up 2% on the 1,165 tests processed in Q2 23 with the quarter-on-quarter increase largely reflecting an increase in test volumes associated with clinical studies in the region.

Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.

[Roskat]

Bruce Quinn MD PhD is an expert on health reform, innovation, and Medicare policy. He helps both large and small companies understand and overcome hurdles to commercialization, as well as craft business strategies for a changing environment. CONTACT Dr. Quinn through www.brucequinn.com. BACKGROUND: Dr. Quinn has worked in academic medicine, Accenture business strategies, and for the Medicare program. EDUCATION: Stanford MD/PhD, MIT Postdoc, Kellogg MBA.

The provided white paper by Bruce Quinn discusses the FDA's proposal to regulate laboratory-developed tests (LDTs) in the United States. It presents several key features and messages:
Overview of the FDA Proposal: The FDA introduced a comprehensive plan to regulate LDTs on September 29, 2023. The FDA proposal aims to bring LDTs under the same regulatory framework as other medical devices, including registration, reporting, and labeling requirements.
Enormous Costs: The paper emphasizes the staggering costs associated with the FDA's plan, estimating it to be around $50 billion over the first few years. This financial burden on the industry is seen as practically unattainable and far exceeding the annual profits of major diagnostic companies.
Timeline Challenges: The FDA's proposed timeline for implementation is considered unrealistic. The transition from a relatively unregulated LDT environment to full compliance with FDA regulations, including submission of 510(k) and PMA applications, within a few years is evaluated as logistically impossible.
Health Benefits: The FDA claims that its proposal will result in significant health benefits, primarily by improving the accuracy of diagnoses and reducing errors associated with LDTs. However, the paper questions the validity of these claims and suggests that they are speculative.
Legal Considerations: The paper highlights the legal controversy surrounding the FDA's authority to regulate LDTs. While the FDA asserts its legal authority, it acknowledges that this is a disputed claim, as demonstrated by the multiplex legal arguments presented in the paper.
Alternative Solutions: Instead of implementing a sweeping regulatory overhaul, the paper suggests alternative solutions achieving the same goals at far less cost. These include:
1) Addressing accuracy by requiring reviews of LDTs at the current "New York State" level, and
2) Addressing concerns about misleading healthcare claims through far less costly means than the FDA's proposed regulations.
Challenges Ahead: The paper concludes that the FDA's proposal, as outlined, faces significant challenges, including industry opposition, legal disputes, and logistical hurdles. It questions the feasibility of executing the plan in its current form.
In summary, the white paper highlights the immense financial burden and practical challenges associated with the FDA's proposal to regulate LDTs. It questions the speculative health benefits cited by the FDA and suggests that more targeted and cost-effective solutions might be more appropriate. Additionally, it underscores the legal controversy surrounding the FDA's authority in this matter. Overall, the paper presents a critical analysis of the FDA's plan, raising doubts about its feasibility and potential impact.



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[winner69]

Interim results Nov 23 ….they’ll rave about great sales and we’ll find how much cash left in kitty

[Roskat]

AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
SUMMARY:
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, FDA is proposing a policy under which FDA intends to phase out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. FDA is proposing this phaseout to better protect the public health by helping to assure the safety and effectiveness of LDTs. If finalized, this phaseout may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable assurance of safety and effectiveness.

[whatsup]

AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
SUMMARY:
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, FDA is proposing a policy under which FDA intends to phase out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. FDA is proposing this phaseout to better protect the public health by helping to assure the safety and effectiveness of LDTs. If finalized, this phaseout may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable assurance of safety and effectiveness.

So in a few words how does this effect PEB ?

[Roskat]

So in a few words how does this effect PEB ?
Hi whatsup. Just an incite into the FDA thinking at the moment re lab testing really.

[850man]

Just published in the US National Library of Medicine "Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients" https://pubmed.ncbi.nlm.nih.gov/37914255/

[carrom74]

Good to see that the team is fighting “ tooth and nail “. The video highlights the cost effectiveness of using Cxbladder and its efficacy. The interview had a big “ no conflict of interest “ clause with PEB which sounds to me as it’s independently researched and peer reviewed

https://www.urotoday.com/transformative-evidence/bladder-cancer-detection/videos/mediaitem/3682-the-promise-potential-and-practicality-of-cxbladder-in-modern-urologic-oncology-mark-tyson-ii.html?mtm_campaign=Tyson_SocialVideo_ID3682&fbclid=IwAR0ENrwZ3gazJKDpNROxkNwVoOq5PRmTf6EM_KRWK dteZIfKrgfS0JzF_7s

[Roskat]

A Lawyer's View: Potential Weakness of FDA Regulation of LDTs (Stacy Amin, Morrison Foerster)

See an excellent new five page analysis of potential weaknesses in FDA's arguments for its LDT regulating authority. By Stacy Amin, former FDA atttorney and now with Morrison & Foerster.
https://assets.contentstack.io/v3/assets/blt5775cc69c999c255/bltff2f4e0cf88d3aac/654d7a74b4ccc3040a594e45/231108-fda-lab-developed-test-rule.pdf
I asked Chat GPT 4 to assess the paper from the perspective of potential legal vulnerabilities of the FDA.
###
The author identifies several potential drawbacks and challenges to the FDA's plan to regulate laboratory-developed tests (LDTs). Here's a detailed summary focusing on those drawbacks:
Litigation Risks: The proposed rule is expected to provoke significant legal challenges, which could be some of the most interesting and precedent-setting ones the FDA has faced in decades (lines 96-98).
Regulatory Skepticism: There is currently a high level of skepticism toward government regulation, and the Supreme Court is reviewing cases that could affect the deference given to agencies like the FDA, which could influence how the FDA's new rule is received and upheld in courts (lines 101-111).
Reliance Interest: Laboratories may argue they have a reliance interest in the FDA's historical enforcement discretion, complicating the agency's efforts to change its policy. The courts' recognition of such reliance interests is still a developing area of law, adding uncertainty to the enforcement of the new rule (lines 120-136).
Historical Precedent and Major Questions Doctrine: The FDA has to counter arguments based on the "major-questions doctrine," which could challenge the agency's authority to regulate LDTs without clear congressional delegation, particularly in the absence of legislation like the VALID Act, which was not passed (lines 139-168).
Scope of FDA Authority: The clinical laboratory industry might argue that the Centers for Medicare and Medicaid Services (CMS) already regulate LDTs through CLIA, and that LDTs are a service rather than a product, thus outside of the FDA's purview (lines 185-193).
Costs and Benefits Dispute: Opponents of the rule may argue that the FDA has underestimated the costs and overestimated the benefits of the new regulation, as well as its ability to manage an influx of marketing applications. They might also argue that the current regulation by CMS and state regulators is adequate, making the new rule's additional costs unjustified (lines 208-218).
Support for the Rule: There is uncertainty about whether those who support the rulemaking have the resources and influence to defend it effectively, especially since previous efforts to pass similar legislation were unsuccessful (lines 226-232).
Forum Shopping: Litigants may seek courts that are historically more sympathetic to their cause, potentially bringing challenges against the FDA in courts that have a history of issuing nationwide injunctions against public health and safety-oriented rulemakings (lines 234-242).
These challenges highlight the complexity and potential difficulties in implementing the FDA's proposed rule on LDTs.

[850man]

Great news! Not only in improving visibility and access for CXB tests but also support of the use of CXB by a sizeable American health insurer https://www.nzx.com/announcements/421662

[whatsup]

Great news! Not only in improving visibility and access for CXB tests but also support of the use of CXB by a sizeable American health insurer https://www.nzx.com/announcements/421662

Off to the races again.

[brutus]

PEB placed first in the Supreme Scale-Ups category in the 2023 TIN Report https://www.linkedin.com/posts/technology-investment-network_taking-out-top-spot-in-the-absolute-it-supreme-activity-7130811735736795136-Uejb

[whatsup]

Results out, despite the s!uff up in the U S good increase in tests for the year.

[bottomfeeder]

Results out, despite the s!uff up in the U S good increase in tests for the year.
50% sounds good, but its 50% on a pitiful amount. At least its in the right direction. They have enough cash going forward a few years, so worth a punt to buy at these prices. Hate those CRs.

[Greekwatchdog]

Its a solid result in difficult circumstances created by the US beauracrats. Be interesting to see how much they are looking at cost saving going forward. Guess we will see that in the full year.

Like to know what is happening with John Hopkins evaluation. Its been 3 years since that was announced. Maybe Covid got in the way there.

[winner69]

Out of curiosity the only number in financials I look at is …


ACCUMULATED LOSSES …. now $232,074,000

It’s increased by $32,000,000 over last 12 months

Pretty good effort over the years eh

[forest]

Out of curiosity the only number in financials I look at is …


ACCUMULATED LOSSES …. now $232,074,000

It’s increased by $32,000,000 over last 12 months

Pretty good effort over the years eh

Some companies say accumulated Tax Losses are an Asset Winner.
So it is all good, the more Tax losses get accumulated the more this asset grows.
With a asset of over $230m PEB must be a bargain.

[bulyak]

To much hurt here from legacy shareholders. Have to now look at it for what it is, and then accept that very few companies on the NZX are actually showing any rev growth. Nothing wrong with a little pressure to reduce costs as well. might be forced into finding some efficiencies in this cash burning machine!!!

[850man]

CMS have given CXBladder Detect+ a reimbursement code eftective 1 Jan 2024 https://www.cms.gov/files/document/r12389cp.pdf

[Retired Doc]

CMS have given CXBladder Detect+ a reimbursement code eftective 1 Jan 2024 https://www.cms.gov/files/document/r12389cp.pdf

Thanks for that! Well spotted wherever you were looking. No trumpets from PEB though??!

[850man]

Thanks for that! Well spotted wherever you were looking. No trumpets from PEB though??!

Still overshaddowed by the Novitas LCD DL39365 unfortunately.

[sunnysleeper11]

Insto in the midst of selling off a decent amount of shares?

[Retired Doc]

Still overshaddowed by the Novitas LCD DL39365 unfortunately.

Which completely overrides clinical utility!!

[850man]

Which completely overrides clinical utility!!

I'm sure if those people in Novitas that want to stop funding CXB had to choose between a cystology or a CXB test, they would continue to fund CXB in a flash!

[nztx]

Whose still buying PEB ?

[Greekwatchdog]

Whose still buying PEB ?

I reckon the ANZ funds...They have been gobbling them up lately

[nztx]

I reckon the ANZ funds...They have been gobbling them up lately


Think you might be right .. averaging down or a bargain near or under NTA ?

[Greekwatchdog]

Think you might be right .. averaging down or a bargain near or under NTA ?

Probably averaging down, given what they have paid. This is just waiting on Novitas to make a decision. If its positive it goes North, Negative who knows..Can't go much lower I guess.

[Greekwatchdog]

ANZ still gobbling them up https://www.nzx.com/announcements/423550

[nztx]

ANZ still gobbling them up https://www.nzx.com/announcements/423550


Who do PEB bank with ? :)

[etrader]

Anz injected $22 mill back in 2020 at 65c then shortly after it spiked to $1.55 then drifted down to the lows, agree they will be securing their average down and I’d be surprised if they keep throwing good money after bad.

Chatting to my broker when the bad news came out they had just over 2 years of funds if the current cash burn continued so they would have tried to reduce some costs in the USA around new staff etc to minimise cash burn.

I’ve invested on and off for 12 years and it definitely had potential to turn big but has taken ages to break through.

It almost needs a major pharmco to grab 20% like J & J where they can scale it to mainstream but those firms around cancer space will have watched hoping they can scoop it up for $10 mill

[Roskat]

FOR IMMEDIATE RELEASE
Jan. 18, 2024
The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) and Dora Hughes, M.D., M.P.H., acting chief medical officer and acting director of the Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS)
Physicians heavily rely on laboratory tests to make critical decisions about their patients’ care—roughly 70% of healthcare decisions depend on laboratory test results according to the Centers for Disease Control and Prevention (CDC). For example, results from laboratory tests can be the sole determinant of whether a patient with cancer gets a particular therapy, potentially risking the patient’s life with an inaccurate test result. Because of the important role of laboratory tests in healthcare decisions, it is essential to ensure these tests work.
While the U.S Food and Drug Administration (FDA) actively oversees tests made outside laboratories by test manufacturers, tests made and run within a single laboratory, known as laboratory, developed tests or LDTs, are often used without such oversight. The FDA’s approach was developed half a century ago when tests made and used in single labs were generally simple, often made to address local individual needs, and mostly manufactured in small volumes. Therefore, the FDA, as a policy approach, generally did not enforce requirements for LDTs. However, since then, LDTs have evolved. Due to the increased risk to patients, it is time to reconsider this approach.
In recent decades, the FDA has identified concerns with a number of LDTs. For example, the FDA is aware of tests offered as LDTs that could have led to patients being over- or under-treated for heart disease; patients with cancer being exposed to inappropriate therapies or not getting effective therapies; and incorrect diagnoses of rare diseases, autism and Alzheimer’s Disease.1 (https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-and-cms-americans-deserve-accurate-and-reliable-diagnostic-tests-wherever-they-are-made?utm_medium=email&utm_source=govdelivery#FN1),2 (https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-and-cms-americans-deserve-accurate-and-reliable-diagnostic-tests-wherever-they-are-made?utm_medium=email&utm_source=govdelivery#FN2) Other evidence, including published literature3 (https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-and-cms-americans-deserve-accurate-and-reliable-diagnostic-tests-wherever-they-are-made?utm_medium=email&utm_source=govdelivery#FN3),4 (https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-and-cms-americans-deserve-accurate-and-reliable-diagnostic-tests-wherever-they-are-made?utm_medium=email&utm_source=govdelivery#FN4),5 (https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-and-cms-americans-deserve-accurate-and-reliable-diagnostic-tests-wherever-they-are-made?utm_medium=email&utm_source=govdelivery#FN5),6 (https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-and-cms-americans-deserve-accurate-and-reliable-diagnostic-tests-wherever-they-are-made?utm_medium=email&utm_source=govdelivery#FN6),7 (https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-and-cms-americans-deserve-accurate-and-reliable-diagnostic-tests-wherever-they-are-made?utm_medium=email&utm_source=govdelivery#FN7),8 (https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-and-cms-americans-deserve-accurate-and-reliable-diagnostic-tests-wherever-they-are-made?utm_medium=email&utm_source=govdelivery#FN8) and the FDA’s experience with tests to diagnose COVID-19,9 (https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-and-cms-americans-deserve-accurate-and-reliable-diagnostic-tests-wherever-they-are-made?utm_medium=email&utm_source=govdelivery#FN9) suggests that the situation is getting worse. Therefore, in October of this year, the FDA issued a notice of proposed rulemaking to help ensure the safety and effectiveness of LDTs by phasing out the FDA’s current approach to LDTs. If finalized, LDTs would generally fall under the same enforcement approach as other tests. The Centers for Medicare & Medicaid Services (CMS) supports the FDA’s proposal.
Both CMS and the FDA believe that patients and their doctors need to know that LDTs are valid. The FDA and CMS both provide oversight to help assure the accuracy of test results, however, they have different roles. CMS regulates laboratories that perform testing on individuals in the U.S. through the Clinical Laboratory Improvement Amendments of 1988 (CLIA) by establishing quality standards for all laboratory testing to help ensure the accuracy, reliability and timeliness of patient test results. In 2013, CMS published a fact sheet (https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/ldt-and-clia_faqs.pdf) on LDTs, outlining each agency’s authority and the complementary roles of the two regulatory schemes. That said, a decade later, in connection with the FDA’s notice of proposed rulemaking, we are – together – reiterating that CMS’s CLIA program is separate in scope and purpose from FDA oversight.
Some have suggested that concerns with LDTs should be addressed through expansion of CLIA. This is not the answer. As was stated in our 2015 testimony (https://democrats-energycommerce.house.gov/committee-activity/hearings/hearing-on-examining-the-regulation-of-diagnostic-tests-and-laboratory), CMS does not have the expertise to assure that tests work; the FDA does. Moreover, establishing a duplicative system for the oversight of tests by expanding CLIA would create more government bureaucracy and inconsistencies. That makes no sense.
The FDA and CMS have long stood together in mutual support of FDA oversight of the analytical and clinical validity of LDTs. LDTs play an important role in healthcare, but when they perform poorly or are not supported by science, they put patients at risk. The current approach has enabled some tests to enter the market with unfounded claims of innovation. These claims can mislead the public, undermine legitimate competition and disincentivize responsible, science-based innovation. Applying the same oversight approach to laboratories and non-laboratories that manufacture tests would better assure the safety and effectiveness of LDTs and would remove a disincentive for non-laboratory manufacturers to develop novel tests that can be available to and used by many laboratories for many patients.
We are now emerging from a global pandemic that has underscored the importance of accurate and reliable tests. Patients and providers need to have confidence that laboratory tests work. We believe the complementary FDA and CMS frameworks are both critical to assuring patients can rely on the clinical accuracy of their test results.

[winner69]

Wow ....what does it say and mean

[Greekwatchdog]

Wow ....what does it say and mean

Well I am scratching my head asking the same question W69. My interpretation is that Novitas has no right to do what its doing because its the FDA's job.

If I am wrong, someone with more medical knowledge please say something. Thanks in advance GWD

[carrom74]

Quarterly update is due anytime. I am expecting it next week.

[Greekwatchdog]

Quarterly update is due anytime. I am expecting it next week.

Agree with you on that.

[mr optimistic]

Interesting update. 15% fall in tests but half the commercial team from 34 to 17. Gotta stop the bleeding. I actually like it.

[frogkiwi]

The way I see it there are two main points in this, first, does the test work and give you the information claimed. FDA say they should be assessing this and approving. Secondly, are your labs up the the standards. CMS should look after this side.
This has probably all been driven by the Novitas stance with the FDA now coming to the party effectively saying this shouldn't be funder driven, this should be clinically driven. We've dropped the ball, thanks for bringing it to our attention, here's how we going to approach this moving forward. This is probably a good thing as it maintains a certain standard and gives physicians some assurance of quality. Lets just hope for the PEB shareholders, PEB has already engaged in dialogue with the FDA and CMS. Once this is completed I would have thought Novitas would then fund any FDA approved test.

[winner69]

Interesting update. 15% fall in tests but half the commercial team from 34 to 17. Gotta stop the bleeding. I actually like it.

Downsizing in both respects

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/425093/411290.pdf

[850man]

I think PEB need to cross the FDA hurdle as top priority if they want to continue in the US market. They have done all they can with Novitas, that is now out of their hands. FDA have approved tests that are far less effective in terms of specificity, NPV and PPV so FDA approval of CXB is entirely possible. The potential future Novitas outcome is funding approval for FDA approved tests. I think this is highly likely.

[winner69]

I think I’m more confused than what PEB were

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/425100/411297.pdf

[frogkiwi]

I think PEB need to cross the FDA hurdle as top priority if they want to continue in the US market. They have done all they can with Novitas, that is now out of their hands. FDA have approved tests that are far less effective in terms of specificity, NPV and PPV so FDA approval of CXB is entirely possible. The potential future Novitas outcome is funding approval for FDA approved tests. I think this is highly likely.

I had a bit of spare time so went looking for the FDA proposal. As far as I can see, in the FDA proposal https://www.federalregister.gov/documents/2023/10/03/2023-21662/medical-devices-laboratory-developed-tests , the date by which they want to go live with the new process is 1 April 2028 (hopefully not an April fools joke). Looks like this is to provide companies time to understand requirements, submit everything they need etc etc.
This is a few years away and raises the question as to what happens with funding in the meantime and what approach will Novitas take while this is being sorted. In a ideal world Novitas would come out with a list of approved tests, CXB included, covered until this date, or they might just leave it all up in the air.
In my opinion after reading this, this isn't about dealing with legitimate tests (hopefully like CXB), rather it sounds like the lack of regulation has allowed a large number of less than sound labs to open and offer some perhaps less than scientifically sound tests with some questionable ethical behavior.

[psychic]

https://scholar.google.co.nz/scholar_url?url=https://www.auanet.org/documents/education/clinical-guidance/NMIBC%2520Amendment%252001-24-24%2520Final.pdf&hl=en&sa=X&d=15554791844504401047&ei=OEG4ZYvJE76Py9YPupq-2As&scisig=AFWwaeaLGaSXEMFseYd-RY9KZTr1&oi=scholaralrt&hist=UBDHjzYAAAAJ:6841515572808951338:AFWwaebpC-tdhwdYMVmg_WpRmU4P&html=&pos=0&folt=kw

AUA has just reviewed Guidelines for use of Urine Tumour Markers but sadly Cxbladder still not recommended. Hope in the future for Cxbladder Monitor perhaps on further evidence.

Not great....

[850man]

From an article today in UroToday "The authors also stated that the future directions of novel urinary biomarkers held promise, citing the CX Bladder platform as an example of how advances can be made in the sensitivity of detecting high-grade NMIBC" Article here http://www.urotoday.com/center-of-excellence/bladder-cancer.html

[psychic]

Ai getting in on the act now.
https://scholar.google.co.nz/scholar_url?url=https://www.nature.com/articles/s41598-024-52728-7&hl=en&sa=X&d=16543069651478828509&ei=e-C-ZYmkH9LFy9YPoL6q0AE&scisig=AFWwaeYRd2e4cTgMOWFZHSkoIzwD&oi=scholaralrt&hist=UBDHjzYAAAAJ:6841515572808951338:AFWwaebpC-tdhwdYMVmg_WpRmU4P&html=&pos=0&folt=kw
Small study but impressive results. Models led to 0.977 sensitivity, 0.972 specificity, and 0.973 accuracy values for the blood samples, and 0.987 sensitivity, 0.829 specificity, and 0.953 accuracy values for the urine (KCl) samples

[Roskat]

Sunday, February 4, 2024Remarkable Pushback Against FDA LDT Regulation: The Hyman Phelps Law Firm Comment

HEADER. I was very impressed by a 58-page FDA LDT comment, submitted by Hyman Phelps law firm and an LDT Coalition.
###
The biggest splash I know of, among FDA LDT comments in December, was that of the ACLA, which was some 100 pages when including an extensive supplement in which an economist took apart the FDA's proposed financials. ACLA entry point here (https://www.discoveriesinhealthpolicy.com/2023/12/acla-issues-107-page-comment-against.html).
Here's another grand example. it comes from Hyman Phelps McNamara and the Coalition to Preserve LDT Access and Innovation. Find it here:
https://www.thefdalawblog.com/wp-content/uploads/2023/12/LDT-Coalition-Comment-12-4-2023.pdf
Topics include:


Prohibitive costs of the rule
Poor presentation of LDT risks and no presentation of LDT benefits
Deeply flawed economic analyses

Multiple categories of costs ignored and underestimated


Existing regulatory framworks are ample
FDA lacks statutory authority

Elaborate statutory discussion


The letter makes a point I have made (https://www.discoveriesinhealthpolicy.com/2024/01/two-extra-thoughts-about-fda-ldt.html), the FDA relies on risk categories by use case and indication, but CLIA tests don't have [in the same sense] statements of indicated use, which at FDA are often verbose, multiplex, and hammered out after months of negotiation (p. 33, 38). ##

[Roskat]

Lengthy but worth the post I guess



Sunday, February 4, 2024Remarkable Pushback Against FDA LDT Regulation: The Hyman Phelps Law Firm Comment

HEADER. I was very impressed by a 58-page FDA LDT comment, submitted by Hyman Phelps law firm and an LDT Coalition.
###
The biggest splash I know of, among FDA LDT comments in December, was that of the ACLA, which was some 100 pages when including an extensive supplement in which an economist took apart the FDA's proposed financials. ACLA entry point here (https://www.discoveriesinhealthpolicy.com/2023/12/acla-issues-107-page-comment-against.html).
Here's another grand example. it comes from Hyman Phelps McNamara and the Coalition to Preserve LDT Access and Innovation. Find it here:
https://www.thefdalawblog.com/wp-content/uploads/2023/12/LDT-Coalition-Comment-12-4-2023.pdf
Topics include:


Prohibitive costs of the rule
Poor presentation of LDT risks and no presentation of LDT benefits
Deeply flawed economic analyses

Multiple categories of costs ignored and underestimated


Existing regulatory framworks are ample
FDA lacks statutory authority

Elaborate statutory discussion


The letter makes a point I have made (https://www.discoveriesinhealthpolicy.com/2024/01/two-extra-thoughts-about-fda-ldt.html), the FDA relies on risk categories by use case and indication, but CLIA tests don't have [in the same sense] statements of indicated use, which at FDA are often verbose, multiplex, and hammered out after months of negotiation (p. 33, 38). ##

[Roskat]

The 58 page report. https://www.thefdalawblog.com/wp-content/uploads/2023/12/LDT-Coalition-Comment-12-4-2023.pdf

[Roskat]

Vision of the Future under FDA LDT Regulation (White Paper) (https://p.feedblitz.com/t3/1128310/208112090/15121445_/~feeds.feedblitz.com/~/871719212/0/discoveriesinhealthpolicy~Decibio-Vision-of-the-Future-under-FDA-LDT-Regulation-White-Paper.html)
The FDA's impending LDT rule, slated for finalization in April 2024, ushers in a transformative shift in the regulatory landscape for laboratory-developed tests (LDTs), bringing them under the same stringent oversight as in vitro diagnostics (IVDs). This comprehensive rule, aimed at safeguarding patient safety and ensuring diagnostic excellence, presents a critical juncture for laboratories utilizing LDTs and life science tools and diagnostic companies whose products form the backbone of LDT workflows. To effectively navigate this regulatory transition, life science tools and diagnostic companies must embark on a proactive strategy, encompassing reassessing their product portfolios, enhancing regulatory and clinical development capabilities, adhering to stringent quality standards, and maintaining close engagement with regulatory authorities. By embracing this proactive approach, they can effectively adapt to the FDA's LDT rule, positioning themselves for success in the rapidly evolving diagnostic landscape and eventually emerge as industry leaders in the dynamic clinical diagnostics arena.

[Roskat]

Very Brief Blog: FDA Sends Final LDT Rule to White House

Header: FDA Sends Finalized LDT Rule to White House OMB/OIRA
##
Moving at a fast pace, FDA has finalized its review of comments on the LDT regulation, and the final regulation was logged at the White House on March 1, 2024. Specifically, the rule is at the Office of Management and Budget (OMB) in the Office of Information and Regulatory Affairs (OIRA).

[Roskat]

About the Authorhttps://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhgrEEbw6omcaq6R1PsCOcMlKKI00H_WVL7zQgA5AKbB5 SqIMyKfplnp5FsnxLFNmL7QKISvQD3EM9MguLQdFtMMwxTsmuO xqWaU30XHIMuvdLXA1w-lwigFRmdmK_sBg/s220/_03A8604.BQ.JPG (https://www.blogger.com/profile/05149672650241065616)Bruce (https://www.blogger.com/profile/05149672650241065616)Bruce Quinn MD PhD is an expert on health reform, innovation, and Medicare policy. He helps both large and small companies understand and overcome hurdles to commercialization, as well as craft business strategies for a changing environment. CONTACT Dr. Quinn through www.brucequinn.com. BACKGROUND: Dr. Quinn has worked in academic medicine, Accenture business strategies, and for the Medicare program. EDUCATION: Stanford MD/PhD, MIT Postdoc, Kellogg MBA.

Friday, March 8, 2024In Writing: My Prediction for FDA LDT, 2024-2031

It was big news in the past week that FDA has sents its final LDT rule to the White House for final sign-off and publication.
https://www.discoveriesinhealthpolicy.com/2024/03/very-brief-blog-fda-sends-final-ldt.html
I'm putting my official multi year policy forecast in writing. Here. Click to enlarge.


https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg_L4ubUP7apNBOmnJ5kX0j8SNC8btJGkfpAbVpn3iSDw Smid4YptH9AgJvHuoVNE3LMiMbC_ClK-qgcq7tQFGYwAlwx4MJbEtNr13NyHeq2pAUiXwQ85fLjqjtd-gxa33qxslAWmsHN_ov62WT3KvJwJlLlZINE9rniIuCWRdWtHSo W8N-OUjydN2kAkA/w504-h272/20240307%20FDA%20LDT%20MAP%20TIME%20YEARS.png (https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg_L4ubUP7apNBOmnJ5kX0j8SNC8btJGkfpAbVpn3iSDw Smid4YptH9AgJvHuoVNE3LMiMbC_ClK-qgcq7tQFGYwAlwx4MJbEtNr13NyHeq2pAUiXwQ85fLjqjtd-gxa33qxslAWmsHN_ov62WT3KvJwJlLlZINE9rniIuCWRdWtHSo W8N-OUjydN2kAkA/s1247/20240307%20FDA%20LDT%20MAP%20TIME%20YEARS.png)


click to enlarge



Discussion.


First, for simplicity, I'm leaving the initial FDA timelines as published in Fall 2023, but I think it is very likely (80%) then will all advance by one year. Regardless, the court case will start immediately.


Second, I think there is a 95% (really, 100%) chance this will tie up in court for several years. Allow 2024 for federal court, 2025 for appeals court, and 2026 if not easily 2027 for Supreme Court.

Third, at Supreme Court, while I am not an attorney, I give a 50% chance the regulation will be tossed out as agency overreach and lack of clear Congressional text governing LDTs. I give a 10% chance that in 2026 or 2027, it will undergo further legal circling like being remanded to a lower court.


This leaves a 40% chance of the regulation being turned back on and its engine revved in 2027 or so.


Fourth, I predict, as in my initial white paper in October 2023 (https://www.discoveriesinhealthpolicy.com/2023/10/online-ahead-of-print-white-paper-on.html), that the rule will have to bog down in several years of delays and deferrals if not worse. By 2029 or 2030 this will lead people to dust off VALID or other alternatives.


##


Offline.

Other possibilties include a 2nd Trump administration that might reverse the rule in a 90-day rulemaking (or un-rulemaking) cycle. Or might more subtly decline to defend it assertively in the court pathway, raising the chance it loses in court.





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[whatsup]

Slip sliding away and not looking good now !!

[snigmac]

Alot of the brokers have bet that the LDT decision will be finalized (in favour of PEB losing funding) and that the price will keep slipping :/

[Balance]

Slip sliding away and not looking good now !!

https://quoteapi.com/resources/da9866271f9d0071/announcements/peb.nzx/427925/PEB_Pacific_Edge_Directors_Give_Notice_of_Retireme nt.pdf?bearer=eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9 .eyJzY29wZSI6WyJndWVzdHMiLCJ1c2VycyJdLCJuYmYiOjE3M TAzNzM5ODYsImV4cCI6MTcxMDM3NDg4NiwiaXNzIjoic3RvY2t uZXNzIiwibm9uY2UiOiJiMDhkZjAyZGZkMDUxMGMyIiwiaWF0I joxNzEwMzczOTg2LCJzdWIiOiIxNDE0MzExMiJ9.TntqfqMCRK n5BNF4gT1hEeEILRkJAiPT0K1uBY8zt38

And it looks like two of the directors (including the Chairman) agree so they are quitting.

Bye bye …

[Roskat]

Published: 03.13.2024Ranking Member Cassidy Seeks Information from Stakeholders on Regulation of Clinical Tests



WASHINGTON – Today, U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, requested information from stakeholders on ways to improve regulation of clinical tests in the United States.
Clinical tests are essential health care resources, informing 70 percent (https://www.cdc.gov/csels/dls/strengthening-clinical-labs.html) of all clinical decisions through diagnosis, screening, staging, and managing of diseases and medical conditions. Since 1976, there have been no significant reforms to the regulation of clinical tests, even as new, innovative tests are being used in health care settings.
Recent efforts by the Food and Drug Administration to unilaterally pursue regulatory reforms through rulemaking go beyond its statutory authority and threaten patient access to timely care. Cassidy rebuked the Biden administration’s executive overreach (https://www.help.senate.gov/ranking/newsroom/press/ranking-member-cassidy-releases-statement-on-fda-proposed-laboratory-developed-tests-rule) and its attempt to bypass Congress on this matter.
Cassidy hopes to use the feedback on how Congress can modernize current regulations to support innovation while ensuring these clinical tests are safe and effective to use. The deadline to submit feedback is April 3, 2024.
Read the full request here (https://www.help.senate.gov/diagnostics-reform-rfi-3-13-24pdf) or below.
To Interested Parties:
Clinical diagnostics play a critical role in our health care system, influencing nearly 70% of all health care decisions. Diagnostic technologies are also the cornerstone of precision medicine and personalized therapies, and as such warrant oversight to ensure regulators are facilitating their continued progress, safety, and accuracy.
Stakeholders and policymakers broadly recognize the need for reform to the regulatory frameworks that oversee laboratory services and diagnostic products. In the nearly 50 years since the Medical Device Amendments (MDA) of 1976 established the Food and Drug Administration’s (FDA) framework for medical devices, advancements in in vitro diagnostic (IVD) technologies have necessitated improvements to this framework to support timely patient access to safe and effective diganostics, especially those intended for special or rare disease populations. At the same time, clinical laboratory medicine has evolved in the 35 years since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) were enacted, demanding standards that reflect advancements in molecular and genomic testing and ensure appropriate oversight over these tests.
In the past, Congress has considered proposals to bring needed reforms to diagnostics regulation. These efforts have been unsuccessful and have resulted in missed opportunities to implement substantive updates to both regulatory frameworks. To further guide ongoing discussion of these matters, I welcome your insights on the following topics, specifically addressing the actions Congress should pursue to meet the challenge of ensuring patient access to timely and advanced diagnostics. Please submit any responses to diagnostics@help.senate.gov by April 3, 2024.

[850man]

A mention of CXBladder as part of in-home care at a recent meeting of the South Eastern Section of the AUA https://www.urotoday.com/conference-highlights/sesaua-2024/150584-sesaua-2024-state-of-the-art-lecture-in-home-therapy-for-bladder-cancer.html

[snigmac]

I'm surprised that Novitas hasn't released a decision yet, it's almost as they want to stretch the coverage.

[Roskat]

Resources: The 3-Hour Congressional FDA LDT Hearing on March 21, 2024 (https://p.feedblitz.com/t3/1128310/208112090/15505925_/~feeds.feedblitz.com/~/874162820/0/discoveriesinhealthpolicy~Resources-The-Hour-Congressional-FDA-LDT-Hearing-on-March.html)

On March 21, 2024, the House Energy & Commerce committee held a 3-hour hearing on the FDA's plan to regulate LDTs. Here are some resources, including a Zip file with all major documents.###The three hour session is online at YouTube here:https://www.youtube.com/watch?v=sQOYPjdTMzU(The YouTube program notes give access to an online YT auto transcript).The House home page for the hearing

[Paint it Black]

Resources: The 3-Hour Congressional FDA LDT Hearing on March 21, 2024 (https://p.feedblitz.com/t3/1128310/208112090/15505925_/~feeds.feedblitz.com/~/874162820/0/discoveriesinhealthpolicy~Resources-The-Hour-Congressional-FDA-LDT-Hearing-on-March.html)

On March 21, 2024, the House Energy & Commerce committee held a 3-hour hearing on the FDA's plan to regulate LDTs. Here are some resources, including a Zip file with all major documents.###The three hour session is online at YouTube here:https://www.youtube.com/watch?v=sQOYPjdTMzU(The YouTube program notes give access to an online YT auto transcript).The House home page for the hearing

Thanks - very interesting commentary from Mrs Rodgers on just how slow the FDA is. She should run for President!
Unfortunately is sums up how dinosaurous the American systems are.

[snigmac]

Is there any indication of how long the hearings will take to wrap up? Is there any chance that they won't be able to conclude the matter until after July 2024, in which case the LCD might not be able to move forward and would be automatically canceled after July 2024?

[psychic]

With both CMS and then perhaps the FDA getting in the way of commercial uptake of cxbladder, Pacific Edgecmight not be too happy with this study just released:

https://www.sciencedirect.com/science/article/pii/S2589537024001457

We know that Cytology and cystoscopy remain the gold standard in diagnosis of bladder cancer. Cytology is highly specific but lacks sensitivity, and hence the development of tumour markers such as cxbladder.
Well these clever fellows have used Ai to improve analysis of cytology and the results after a four year large cohort study suggest significant improvement in sensitivity, above that of Fish and Cxbladder.
As with all these things, further studies are needed but I am really starting to think that we have missed the boat here

[snigmac]

With both CMS and then perhaps the FDA getting in the way of commercial uptake of cxbladder, Pacific Edgecmight not be too happy with this study just released:

https://www.sciencedirect.com/science/article/pii/S2589537024001457

We know that Cytology and cystoscopy remain the gold standard in diagnosis of bladder cancer. Cytology is highly specific but lacks sensitivity, and hence the development of tumour markers such as cxbladder.
Well these clever fellows have used Ai to improve analysis of cytology and the results after a four year large cohort study suggest significant improvement in sensitivity, above that of Fish and Cxbladder.
As with all these things, further studies are needed but I am really starting to think that we have missed the boat here

The AI appears to use information from a cytology and cystoscopy, which are both invasive tests. I think this test is neutral when it comes to what PEB are doing.

[psychic]

The AI appears to use information from a cytology and cystoscopy, which are both invasive tests. I think this test is neutral when it comes to what PEB are doing.

Couldn't agree less!

[snigmac]

The AI appears to use information from a cytology and cystoscopy, which are both invasive tests. I think this test is neutral when it comes to what PEB are doing.
Looks like I missed that the AI used images from cytology tests only which aren't invasive. It sounds like a fair bit of work is still required re the AI power of this test though.

[850man]

A lot of the commentary about the efficacy of CXB references the original test suite. The enhanced CXB tests are a step up in sensitivity and NPV / PPV. NPV on CXB+ is 100%. That said, I'm not sure how much the enhanced tests are being promoted by PEB. A lot hinges on the Novitas outcome

[whatsup]

Latest qr test numbers holding steady but cannot read anything into this as imo PEB's future is out of its hands for now !

[winner69]

Latest qr test numbers holding steady but cannot read anything into this as imo PEB's future is out of its hands for now !

Still demonstrating resilience they say

[Balance]

Still demonstrating resilience they say

Dying a slow death.

[Schrodinger]

Dying a slow death.

Did we hit 10,000 tests?

[Balance]

Did we hit 10,000 tests?

You mean ‘tens of thousands’ uttered by Chairman Swain over 10 years ago?

[Schrodinger]

Yes - ten years back? I think the accumulated losses are $200m+?

[snigmac]

The information in the investor update looks good. I wouldn't be surprised if Novitas let the LCD laspse and then trigger another LCD after to keep PEB on their toes to produce data.