PEB - Pacific Edge Ltd

[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

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

[FONT="]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
[/FONT]

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/scienc...89537024001457

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/scienc...89537024001457

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 !