PEB - Pacific Edge Ltd

**calledone** · 02-01-2021, 07:43 PM

Is the following something of a concern? This guideline is effective from 1st Jan 2021.

On page 296:

- The current diagnostic performance of biomarkers are inadequate to replace cystoscopy in the primary hematuria setting.”

- “Given the current evidence, the use of these markers as an adjunct to cystoscopy for the evaluation of hematuria should be considered investigational.”

https://www.evicore.com/-/media/file...ub08312020.pdf

**Longhaul** · 02-01-2021, 08:47 PM

Originally Posted by calledone

Is the following something of a concern? This guideline is effective from 1st Jan 2021.

On page 296:

- The current diagnostic performance of biomarkers are inadequate to replace cystoscopy in the primary hematuria setting.”

- “Given the current evidence, the use of these markers as an adjunct to cystoscopy for the evaluation of hematuria should be considered investigational.”

https://www.evicore.com/-/media/file...ub08312020.pdf

In my opinion, not really concerning. In fact I would suggest that these two statements you've highlighted do not preclude the use of cxBladder.

My plain English interpretation of the above is:

1) don't use a biomarker instead of cystoscopy - I don't think PEB have ever suggested this but someone correct me if I'm wrong.

2) Use these biomarkers with cystoscopy for investigative purposes - I would have thought this is EXACTLY how the cxBladder suite of products is supposed to be used.

In the longer term I would like to see cxBladder replace cytology, and become the biomarker of choice for physicians and the Holy Grail is to eventually be recommended in the AUA guidelines.

**Minerbarejet** · 02-01-2021, 08:48 PM

Look at the dates on the references.

Also the latest seems to be to use cxBladder with imaging in a triage situation.

cxBladder was to be used as an adjunct to cystoscopy but in some cases it seems to be superior not just for convenience but actual results.

One of the main reasons I invested in PEB was because of the fact that in the original trials 4 extra cancers were detected that Cystoscopy could

not find.

**calledone** · 02-01-2021, 09:21 PM

Originally Posted by Minerbarejet

Look at the dates on the references.

Also the latest seems to be to use cxBladder with imaging in a triage situation.

cxBladder was to be used as an adjunct to cystoscopy but in some cases it seems to be superior not just for convenience but actual results.

One of the main reasons I invested in PEB was because of the fact that in the original trials 4 extra cancers were detected that Cystoscopy could

not find.

Thanks, just saw the dates on the references. I wonder why they make guidelines based on old research while new studies are available!

**Minerbarejet** · 03-01-2021, 07:55 AM

Fear of litigation in a nation run by lawyers.

Looks to me like somebody got onto the CMS and told them to stop fluffing around and get this stuff out there.

No clues as to who that might have been though.

**Mel** · 07-01-2021, 10:03 PM

Question that I haven't got around to asking.......I was very late to the investor presentation and was curious about whether there was any reference or updates on the CMS reimbursements at this forum prior to my arrival? Thanks in advance

**Retired Doc** · 08-01-2021, 01:58 PM

IMHO the AUA will be very conservative and fear of litigation will be an influence re substituting Cxb for cystoscopy. However it must be remembered there is a morbidity associated with cystoscopy particularly if a general is used which it sometimes is. Patient preference will eventually win the day if urologists don’t adopt but I am sure they will.