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."

[Greekwatchdog]

Interesting, if not a little frustrating if Novitas say no

Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes the US District Court for the Middle District of Pennsylvania has determined that it does not have jurisdiction to conduct judicial review of 'Genetic Testing in Oncology: Specific Tests' (L39365) Local Coverage Determination.The judgment means the court is not able to consider the merits of Pacific Edge's legal complaint filed in the US District Court on 19 February 2025 about the LCD, despite Judge Neary noting in her ruling that "the company has also marshalled incredibly compelling facts for why its test is a medical marvel."The judgment was published around 4:15pm ET on 23 April 2025 and means the remaining avenue for L39365 not to become effective on 24 April 2025 in the USA is a policy action by the Center of Medicare and Medicaid Services (CMS).CMS has the authority to unilaterally extend the effective date of L39365 independent of the Court's ruling. Pacific Edge and associated parties have made the case for retirement of the LCD or extension of the effective date to the incoming political appointees within CMS , HHS and OGC . Pacific Edge is continuing to watch closely to determine what action, if any, CMS will take and we will update the market as we receive further information.

[Poet]

Is anyone able to comment on what this ruling means for PEB in terms of legal recourse against the LCD.

In declining jurisdiction, has the District Court effectively said that there is no route for a legal challenge in any court?

Or is it now a matter of re-filing in a court that does have jurisdiction?

[Left Field]

Mmmmm the rationale, expense and legal advice as to why PEB chose to file this action with a Middle District court in Pennsylvania needs to be reviewed. Clearly not the right course of action.

However the judges unprompted opinion that "the company has also marshalled incredibly compelling facts for why its test is a medical marvel" is encouraging for further legal action if needed.

Meanwhile investors wait for an update on Novitas's decision due tomorrow 24 April (US time.)


ps Poet - I think your last point regarding re-filing is the correct possible future action for PEB ..... but only if tomorrow's Novitas possible decision is unfavourable.

[raW tent Buffer]

Not sure why but PEB have not been very transparent about their legal challenge to the LCD. You would have thought if there was another route to challenge this legally they would have mentioned it in that announcement. Sounds like they're just hoping for CMS to come to the rescue at the 11th hour.

It's not looking good brev

[Greekwatchdog]

It's not looking good brev
[/quote]

The fact its in the AUA guidelines is a total game changer.
Whilst they don't have to use it, they are advised to follow best practice.

If they say no it goes against the AUA and all the other evidence been presented.

I think they ask for another extension.

[raW tent Buffer]

The LCD goes into effect tomorrow. The last extension was made more than 3 weeks prior to the implementation date. Don't you think Novitas have left it a bit late if they were going to extend it?

I hope they extend it but there's nothing about Novitas that fills me with optimism.

[Poet]

The LCD goes into effect tomorrow. The last extension was made more than 3 weeks prior to the implementation date. Don't you think Novitas have left it a bit late if they were going to extend it?

I hope they extend it but there's nothing about Novitas that fills me with optimism.

Novitas might have been waiting for the outcome of the court case before jumping one way or another. I think the court's comment re 'compelling facts' and 'medical marvel' give a clear steer on what ruling would be forthcoming if they manage to get the case in front of a court that does have jurisdiction.

[Greekwatchdog]

The LCD goes into effect tomorrow. The last extension was made more than 3 weeks prior to the implementation date. Don't you think Novitas have left it a bit late if they were going to extend it?

I hope they extend it but there's nothing about Novitas that fills me with optimism.

Honestly who would know. I mean the AUA inclusion in guidelines was such a feat saying no is dumb arse move given the positives to the patient and payer. Hey its the US and the land of stupidity

[Poet]

yeah exactly. they could (and should imo) have turned round and reversed the LCD immediately after the AUA inclusion, there's been no reason to delay til now to do it, hence I feel it's unlikely they will do anything tomorrow and the LCD will come into effect. who knows though.


fingers crossed because it's a product that helps people with a horrible disease and it works.

Tim Hunter in NBR has some interesting comments from PEB and some background to court decision
https://www.nbr.co.nz/investment/us-court-declines-to-intervene-in-pacific-edge-funding-crisis/


In short
PEB still hopeful that decision will be positive and Novitas rescinded an order within a couple of hours of implementation deadline just recently
There are avenues for appeal once a negative decision takes effect
PEB has some political support and lobbying in place