PEB - Pacific Edge Ltd

[kiwidollabill]

And you want to look at some very disruptive technology? There is a BD/Bruker Biotyper https://www.bruker.com/products/mass.../overview.html in every major microbiology lab in NZ. Delivered and used well before CE-IVD approval - this has been the first big change in the 'detection' part of the workflow in the last 30 years.

[twotic]

So c'mon now twotic. Share the love. What is the goss frontline NZ that gave you doubts on actual performance? I certainly would not ignore it and am genuinely interested.

Do you rate our health boards in adopting new technology? Did they or the Urologists you spoke to adopt UroVysion or even nmp22 for that matter?

In March this year the NZ National Health Committee issued this -

http://nhc.health.govt.nz/system/fil...turia-t2-a.pdf

It screams out for Triage - and they are clearly working towards it. But the wheels turn so slowly. Too slow for many here for sure.

You also mention AHRQ. Do you have any info that I have missed? To my knowledge there has only been a draft issued, the delayed final was to have been published first in the US Spring, then they told me by 31st August. I'm still waiting.

If anything the Draft damns the competition by concluding that Urinary biomarkers miss a substantial proportion of patients with bladder cancer. (Tell that to the market using UroVysion and NMP22.) It actually acknowledges that CxBladder Detect outperforms the other markers under review, but it's performance is not considered simply because the strength of evidence is comparatively low (data from one NZ study only)

It is a summary document only after all.

And the delays are intriguing. There is more evidence now, AND there is Triage. Triage, if included, might almost make the the whole thing redundant.

Gidday Psychic,

Perhaps nothing you don't already know from our past conversations. As you can appreciate I can't reveal names etc but I my information comes via researchers and urologists in NZ, and more recently (living down in Dunedin) people at Otago Uni.

Adoption of new technology? well it comes down to a combination of the funding that is available for new tests/treatments (which is usually zilch), potential cost savings, and evidence of accuracy/effectiveness of treatmnets/test etc. Paraphrasing the responses I have had: There is not enough funding to adopt CxBladder as a new test and not enough evidence to move out of line with international guidelines.

On the other hand I was told that some DHBs are introducing the test to triage microscopic haematuria referrals. These patients generally wait months to be seen because the hit rate is so low (<1%) so the logic is you can bring them in quicker and if they test positive. The issue there though is that there is no direct cost savings, and despite obvious potential gains in patient safety, cost savings is the key.

In terms of the AHRQ report, I guess it started to make me think I wasn't seeing the woods for the trees. I agree the evidence base appears to be growing showing CxBladder outperforms its peers, but the headline conclusion in the draft AHRQ report basically says there is not enough evidence to suggest biomarker tests are good enough to become part of the best practise clinical pathway. No-one paid much attention to that conclusion as I think people were a bit too focussed on how good CxBladder is vs its peers. BUT if as a group none of them are good enough IMO it doesn't really matter if CxBladder is the best of what is available. Someone said the AHRQ report had its funding cut, so I am not sure we see a final report. That being said I don't believe there is anything recent that would change their headline conclusion.

Regarding the NHC. I'm not surprised the wheels are turning so slowly. If you have ever visited or worked with them you will know why. They are severely underfunded/understaffed. I suspect when people hear "National Health Council" they think about quite a large organisation. Infact last I knew it was a team of about 6 people attempting to do a job which in my opinion should have about 50. They are good people there, but are kicking **** up a hill if you like when it comes do getting stuff done. I'm not sure how much influence they actually have as well.

[zs_cecil]

Jeepers, that is quite a range you've identified so Im not sure how useful it is? Interested to know how you came up with it though.

The number is interesting though I think despite no proof. Australia FY2015 ended at the end of Jun 2015. There might be some amounts of done tests that will be count as the income for PEB FY2016.

Let's assume 37,777 (medium value of the given range) tests have been carried out. Each test is cost $200 NZD. The total revenue of these tests will be $7,555,400.
The sales revenue in PEB FY2015 result, $1,899,665. This means $5,655,735 revenue will be booked in PEB FY 2016.

Just my optimistic guess.

[twotic]

It's just that the upper end of you range is nearly 10 x the lower end. I guess my question then is how reliable is that range?

[twotic]

Psychic, I just re-read that NHC report. Yup I guess they are "screaming out" for biomarker tests, but does so with the caveat that the evidence base is still not good enough and "further analytical work is appropriate on the use of urinary biomarkertests in the diagnostic pathway for haematuria, examining their effectiveness and cost-effectiveness.A particular focus should be on those tests that show high sensitivity ".

I guess the reality is that in many disciplines people are screaming out for better/cheaper/more effective products but until one is developed and proven I'm not sure it means much.

Just my opinion of course and with everything I have posted it is worth pointing out I am just an interested bystander with no experience of formal education in much of this subject matter, so grain of salt and all that

[zs_cecil]

It's just that the upper end of you range is nearly 10 x the lower end. I guess my question then is how reliable is that range?

Yeah, that's my question too. Does anyone remember if any previous announcement from PEB or Cellmid has the information of how the royalty fee is paid?

[twotic]

Yeah, that's my question too. Does anyone remember if any previous announcement from PEB or Cellmid has the information of how the royalty fee is paid?

Sorry got you confused with the original poster. Let's see if he/she can elaborate a bit.

[psychic]

Gidday Psychic,

Perhaps nothing you don't already know from our past conversations. As you can appreciate I can't reveal names etc but I my information comes via researchers and urologists in NZ, and more recently (living down in Dunedin) people at Otago Uni.

Adoption of new technology? well it comes down to a combination of the funding that is available for new tests/treatments (which is usually zilch), potential cost savings, and evidence of accuracy/effectiveness of treatmnets/test etc. Paraphrasing the responses I have had: There is not enough funding to adopt CxBladder as a new test and not enough evidence to move out of line with international guidelines.

On the other hand I was told that some DHBs are introducing the test to triage microscopic haematuria referrals. These patients generally wait months to be seen because the hit rate is so low (<1%) so the logic is you can bring them in quicker and if they test positive. The issue there though is that there is no direct cost savings, and despite obvious potential gains in patient safety, cost savings is the key.

In terms of the AHRQ report, I guess it started to make me think I wasn't seeing the woods for the trees. I agree the evidence base appears to be growing showing CxBladder outperforms its peers, but the headline conclusion in the draft AHRQ report basically says there is not enough evidence to suggest biomarker tests are good enough to become part of the best practise clinical pathway. No-one paid much attention to that conclusion as I think people were a bit too focussed on how good CxBladder is vs its peers. BUT if as a group none of them are good enough IMO it doesn't really matter if CxBladder is the best of what is available. Someone said the AHRQ report had its funding cut, so I am not sure we see a final report. That being said I don't believe there is anything recent that would change their headline conclusion.

Regarding the NHC. I'm not surprised the wheels are turning so slowly. If you have ever visited or worked with them you will know why. They are severely underfunded/understaffed. I suspect when people hear "National Health Council" they think about quite a large organisation. Infact last I knew it was a team of about 6 people attempting to do a job which in my opinion should have about 50. They are good people there, but are kicking **** up a hill if you like when it comes do getting stuff done. I'm not sure how much influence they actually have as well.

Psychic, I just re-read that NHC report. Yup I guess they are "screaming out" for biomarker tests, but does so with the caveat that the evidence base is still not good enough and "further analytical work is appropriate on the use of urinary biomarkertests in the diagnostic pathway for haematuria, examining their effectiveness and cost-effectiveness.A particular focus should be on those tests that show high sensitivity ".

I guess the reality is that in many disciplines people are screaming out for better/cheaper/more effective products but until one is developed and proven I'm not sure it means much.

Just my opinion of course and with everything I have posted it is worth pointing out I am just an interested bystander with no experience of formal education in much of this subject matter, so grain of salt and all that

Cheers twotic.

Maybe it's the ol confirmation bias kicking in, BUT:

1. NHC Report. They use data from Detect - not Triage. They say in 10.3 "any alternative diagnostic tool to be implemented would need to be effective in ruling out bladder cancer. That is, the test would need to demonstrate a high negative predictive value" . So PEB give them just that, CxBladder Triage with NPV 98% and sensitivity 95%. Annnnndddd - nothing. It is exactly what they want, and the NHC's own figures support utility.

So frustrating!!!

AHRQ
Again - Triage not considered at all (predates launch and published study so fair enough) but my interpretation is that they don't even factor Detect into the conclusion because there is only the one study considered and so insufficient. But regardless - Detect outperforms the others, and despite the AHRQ poo pooing biomarkers generally, they are part of clinical practice in the US and a mighty significant earner.

PEB is only chasing down 10% of that market to get to their $100m , so not unrealistic.

[twotic]

Cheers twotic.

Maybe it's the ol confirmation bias kicking in, BUT:

1. NHC Report. They use data from Detect - not Triage. They say in 10.3 "any alternative diagnostic tool to be implemented would need to be effective in ruling out bladder cancer. That is, the test would need to demonstrate a high negative predictive value" . So PEB give them just that, CxBladder Triage with NPV 98% and sensitivity 95%. Annnnndddd - nothing. It is exactly what they want, and the NHC's own figures support utility.

So frustrating!!!

AHRQ
Again - Triage not considered at all (predates launch and published study so fair enough) but my interpretation is that they don't even factor Detect into the conclusion because there is only the one study considered and so insufficient. But regardless - Detect outperforms the others, and despite the AHRQ poo pooing biomarkers generally, they are part of clinical practice in the US and a mighty significant earner.

PEB is only chasing down 10% of that market to get to their $100m , so not unrealistic.

Quite possibly mate - I think that is often inevitable with a lot of people so I won't deny it. That being said, you know I had been concerned for some time before I sold my last parcel.

I must admit, I am often lumping all the different tests together when I'm talking about their prospects of being included in best practise clinical pathway. It takes quite a lot of work to recall the details of each test, NPVs, PPVs, sensitivity, specificity etc etc, then remember what test is what and where it slots into the clinical pathway. Hence my disclaimer about my interpretation of it all. You know more about it all that me now for sure. At the end of the day I just needed to make a call on my holdings and as I do with a lot of stocks I set a few markers in the sand and hold or sell depending on my interpretation of the results.

It would be good to get a consensus opinion from urologists both in NZ and the US as to the prospects of these tests being included in international guidelines for best practise. That would make it a heck of a lot easier for all of us.

Good luck mate. I do hope it works out!

[psychic]

Cheers mate - No , I meant the probable confirmation bias was mine - not yours.

The whole Healthcare process is a riddle to me. I mean you have the likes of AHRQ set up to advise other Departments in the US on these things, and blow me, CMS don't follow AHRQ recommendations. We have this NHC in NZ, reaching logical conclusions regarding patients presenting with Haematuria, studies backed up by our own DHB's, and they still drag their feet. (I bet they will jump on the US acceptance post KP trial...)

It is a slow moving train for sure. Gives holders the heebies and the stone throwers something easy to aim for.

Very much appreciate your keeping an ear to the ground as you drift about Otago. Cheers