PEB - Pacific Edge Ltd

[psychic]

It's on the PEB website. Some of it is here
https://www.pacificedgedx.com/news-a...-medicare-lcd/ ,but the information will be scattered across a few pages.

Been around too long to accept what Pacific Edge say..
Have you seen any evidence to support claim that these groups support Detects inclusion?

[snigmac]

A query- what if there is no decision made in the times mentioned. BAU??

Been around too long to accept what Pacific Edge say..
Have you seen any evidence to support claim that these groups support Detects inclusion?

Nothing specific about Detect but Cxbladder is mentioned expressly in their letter and the groups advocate for Medicare coveragw for Cxbladder to be kept. There letter can e donnloaded here: https://www.pacificedgedx.com/assets...CD-DL39365.pdf

[psychic]

Nothing specific about Detect but Cxbladder is mentioned expressly in their letter and the groups advocate for Medicare coveragw for Cxbladder to be kept. There letter can e donnloaded here: https://www.pacificedgedx.com/assets...CD-DL39365.pdf

Thank you. Note as a group they argue for the continued inclusion of approved Biomarkers generally and agree, they speak positively of the results of the unpublished Kaiser findings. But note that AUA does not include the use of Cxbladder in its own Clinical Guidelines....
Wouldn't you think the AUA would first change their guidelines if Cxbladder had their support?

[carrom74]

Thank you. Note as a group they argue for the continued inclusion of approved Biomarkers generally and agree, they speak positively of the results of the unpublished Kaiser findings. But note that AUA does not include the use of Cxbladder in its own Clinical Guidelines....
Wouldn't you think the AUA would first change their guidelines if Cxbladder had their support?

A podium presentation of the clinical utility was part of the just concluded AUA conference.Not sure what weight this would carry but worth to note that this conference was attended by a lot of urologists across the world.

https://api.nzx.com/public/announcem...284-417563.pdf

[snigmac]

A query- what if there is no decision made in the times mentioned. BAU??

I'm not an expert on AUA and guidelines. Reading between the lines, I think it takes time and research for inclusion. I think PEB is gunning for inclusion in guidelines, it's just not there yet. AUA is expressly supportive of the PEB tests and they have noted this in their letter. I think the safest thing for Novitas to do is to trigger another modified LCD and give PEB another year of coverage.

[psychic]

A podium presentation of the clinical utility was part of the just concluded AUA conference.Not sure what weight this would carry but worth to note that this conference was attended by a lot of urologists across the world.

https://api.nzx.com/public/announcem...284-417563.pdf

Yeah, been multiple CxBladder podium presentations over the years at AUA Conferences

[carrom74]

Yeah, been multiple CxBladder podium presentations over the years at AUA Conferences

This time though on a randomised STRATA study… randomised but funded by PEB.

[psychic]

I'm not an expert on AUA and guidelines. Reading between the lines, I think it takes time and research for inclusion. I think PEB is gunning for inclusion in guidelines, it's just not there yet. AUA is expressly supportive of the PEB tests and they have noted this in their letter. I think the safest thing for Novitas to do is to trigger another modified LCD and give PEB another year of coverage.

From the 2024 AUA guidelines
In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)

[snigmac]

From the 2024 AUA guidelines
In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)

This is a article pushed out a few days ago: https://auanews.net/issues/articles/...cer-management .Cxbladder is mentioned and biomarkers are talked about favorably. The science is getting there... just not sure how far or close it is for inclusion...

There is also a part that comments on guidelines:

AUA guidelines do not currently recommend the use of urinary biomarkers to replace cystoscopy, but they do provide two clinical scenarios where biomarkers may be useful: (1) to adjudicate equivocal cytology or indeterminate cystoscopic findings and (2) to assess response to bacillus Calmette-Guérin (BCG).

[psychic]

Yes, article talks generally about biomarkers, not written by AUA as such. Big mention re opposition too.

In the two clinical scenarios you refer to the biomarkers approved are UroVysion Fish and Immunocyt, not CxBladder.

Totally agree, getting there. But still seems some way off.