PEB-Pacific Edge

[Pierre]

Here are a couple of interesting quotes from today's PEB Investor Update relating to the recent inclusion of CxB in the AUA guidelines:

"The biggest short-term opportunity is to leverage the guideline language in our ongoing policy dialogue and legal action with Novitas and our engagement with the Centers for Medicare and Medicaid Services (CMS) over the adverse 'Genetic Testing in Oncology: Specific Tests' (L39365) local coverage determination (LCD)"

It confirms that PEB is engaged in some kind of (unspecified) legal action with Novitas. Hopefully, this will result in continuance of coverage for CMS reimbursement.

While continued CMS coverage is the desired outcome, PEB expects testing volumes and revenue to increase (though obviously at a lower rate) regardless of the Novitas outcome.

"From a business perspective, the guideline is a substantial strategic milestone on which to build our commercial operations. We expect the guideline to catalyze increased testing volume and revenue despite coverage uncertainty. Similarly, we expect this to drive medical policy and commercial contracting conversations with the vast number of healthcare plans in the US such as those with Blue Cross Blue Shield.."

[bulltrap]

You missed the key point in the headline from your quote.

It actually reads:
Q4 25 Cxbladder Volumes Rise and Key Metrics Improve

It's up 5% year-on-year - compare total 7577 in Q4 25 to 7201 tests in Q4 24.

In the past they did mention YoY (e.g. Q3 23), along with mumbling about seasonal variations to explain QoQ. Now we just get the mumbling.

Disc: Holding and expecting better

[Greekwatchdog]

Posted by Psychic on the other site

PE/ Kaiser study results published for Cxbladder Triage.

https://www.auajournals.org/doi/abs/...88.99555.df.11

RESULTS:
Rates of cystoscopy were much lower (3.9%) in those with a low-risk Triage result compared to their matched comparison group without a test (42.5%), while those whose Triage result recommended physician-directed protocol had a much higher rate (72.9%) than their matched comparison group (41.4%).

CONCLUSIONS:
These data reveal that CxBladder Triage testing resulted in significantly decreased cystoscopy and imaging utilization in those classified as low risk, while simultaneously demonstrating increases in the cystoscopy and bladder cancer detection rate in the physician directed protocol group. Further systematic evaluations of the Triage test are warranted to reduce the burden of unnecessary cystoscopy.

[Greekwatchdog]

Posted by Psychic on the other site
 
https://scholar.google.co.nz/scholar...&pos=0&folt=kw

PE funded Cxbladder Monitor study results

Results: Compared with SOC, CxbM reduced mean total costs by $68,621 for 100
patients over 5 years or $137.24 per patient per year. Cystoscopy was reduced by
129 (0.31 per patient per year), and there was no difference in delayed cancer
diagnosis. Using a probabilistic model, the median cost reduction per patient per
year was $160 (95% credible interval 520 to 109) with 86.2% probability of cost
savings.
Conclusions: In this Markov model, incorporation of CxbM into surveillance for
NMIBC reduced cystoscopy without negative impact on cancer detection with
cost savings for the majority of simulations run.

[850man]

Posted by Psychic on the other site

PE/ Kaiser study results published for Cxbladder Triage.

https://www.auajournals.org/doi/abs/...88.99555.df.11

RESULTS:
Rates of cystoscopy were much lower (3.9%) in those with a low-risk Triage result compared to their matched comparison group without a test (42.5%), while those whose Triage result recommended physician-directed protocol had a much higher rate (72.9%) than their matched comparison group (41.4%).

CONCLUSIONS:
These data reveal that CxBladder Triage testing resulted in significantly decreased cystoscopy and imaging utilization in those classified as low risk, while simultaneously demonstrating increases in the cystoscopy and bladder cancer detection rate in the physician directed protocol group. Further systematic evaluations of the Triage test are warranted to reduce the burden of unnecessary cystoscopy.

What is very important in this study is n=2754. That is a very significant sample size.

[Left Field]

PEB to feature at the next AUA conference April 26 to 29..... ( interesting as this timing follows the due date for the expected decision from Novitas of 24 April 2025 (US Time) )

Release from PEB today.



Cxbladder's Clinical Utility in Focus at AUA 2025


Recognition of Cxbladder's clinical and economic value in evaluating patients presenting with hematuria is set to gain momentum at the American Urological Association's (AUA) Annual Meeting, April 26–29 in Las Vegas.

A plenary session at the meeting will highlight Cxbladder Triage's inclusion in the AUA's new microhematuria guideline released in February 2025. Additional sessions will cover a large real-world study by Kaiser Permanente2 confirming the clinical utility of Triage, and preliminary results3 from the DRIVE study focused on the clinical validation of Triage Plus.

These sessions are a significant opportunity for Pacific Edge to deepen market understanding of Cxbladder's performance and drive its broader clinical adoption.Pacific Edge Chief Executive Dr Peter Meintjes said: "Guideline amendments are always significant talking points at an AUA meeting. However, with urine biomarkers getting their first positive inclusion language in the microhematuria guideline4 and Cxbladder Triage being the first and only biomarker to receive a 'Grade A'5 evidence, this year is bigger than most, and the plenary session provides a great platform for how Pacific Edge is improving the standard of patient care.

"The Kaiser Permanente study is important because it demonstrates the real-world impact of Cxbladder Triage with tremendous statistical power given the sample size of 3,353 patients. The design of the study prospectively managed hematuria patients according to the new Triage-based standard of care and then retrospectively compared those clinical outcomes to a cohort of "risk-matched" patients from Kaiser Permanente nation-wide EMR who did not. This kind of study and evidence generation is uniquely available in the Kaiser Permanente system and underscores the value of our partnership and our shared commitment to improving patient outcomes.

"The DRIVE study will be presented in the Urological Society of American Veterans (USAV) session at the AUA to showcase preliminary clinical validity results for Triage Plus for the evaluation of hematuria in a Veterans population. These data are important for establishing a local coverage determination for Triage Plus with Novitas, and as validation for the US Veterans Administration to consider incorporating Cxbladder into its facilities."