PEB-Pacific Edge

[Pierre]

Yeehah!

[LoungeLizard]

SP up 135% - not a bad day at the office!

Today's decision makes one wonder where the SP may go when or if Novitas finally do the right thing and re-instate coverage. Back in the good old days, before the Novitas mess and Covid, the SP was up in the $1.50's. Arguably the company is in better shape in terms of product development and exposure now, so one would think $1.50 could again be achievable. But, having been bitten badly over the last few years, I suspect investors will want to see the financials improve first, particularly becoming cash flow positive.

And on that, if Novitas do come to the party, then a capital raise would probably immediately be called, to ride the wave of optimism and to scale the orgainisation back up again.

Hopefully todays decision may get a few institutional investors interested and we may see the SP continue to climb!

[Left Field]

Great news for holders.....

AUA guidelines inclusion gives PEB the upper hand in any further negotiations (or legal action) with Novitas IMHO.

Onwards and upwards at long last!



Cxbladder Incorporated into AUA Clinical Guideline

New AUA microhematuria guideline incorporates language for urine-based biomarkers in appropriately counseled intermediate-risk patients 
Guideline specifically mentions Cxbladder Triage as the only urine biomarker with 'Grade A' evidence
Intermediate-risk patients represent an estimated 70%2 of those presenting with microhematuria

Dear Shareholder,
Pacific Edge today announces the American Urological Association (AUA) has included Cxbladder Triage as the standard of care in an amendment to its clinical guideline for the management of patients presenting with microhematuria.3

In a major amendment to the 2020 AUA microhematuria guideline4, the Panel has incorporated language for the use of urine-based biomarkers for intermediate-risk patients. It specifically mentions Cxbladder Triage as the only urine-based biomarker test that has 'Grade A' evidence from a randomized controlled trial (the STRATA Study5) in support of this recommendation. Intermediate-risk patients represent a large cohort (estimated at 70%) of microhematuria patients, and future evidence being generated in Pacific Edge's CREDIBLE Study for the next generation test Triage Plus is designed to apply beyond the intermediate-risk hematuria patients.

The guideline states: "In appropriately counseled intermediate-risk patients who want to avoid cystoscopy and accept the risk of forgoing direct visual inspection of the bladder urothelium, clinicians may offer urine cytology or validated urine-based tumor markers (Table 5 included in this release) to facilitate the decision regarding utility of cystoscopy. Renal and bladder ultrasound should still be performed in these cases."

The AUA amendment specifically references the latest evidence generated from the STRATA Study following its publication in the Journal of Urology in May 2024. The study demonstrated in a randomized controlled trial, a first for any urine biomarker, that Cxbladder Triage could safely and effectively reduce cystoscopies by as much as 59% without missing tumors. This result paves the way for future Cxbladder products such as Cxbladder Triage Plus to be demonstrate equivalent or better performance than Cxbladder Triage for future guideline acceptance.

As a consequence of the new guideline, Pacific Edge anticipates an uplift in demand for Cxbladder tests as more clinicians in the US and around the world begin to observe this updated guideline and incorporate the tests into care pathways for the evaluation and management of patients presenting with microhematuria.

Pacific Edge also expects to leverage the guideline language in its ongoing policy dialogue with Medicare Administrative Contractor Novitas and the Centers for Medicare and Medicaid services over the 'Genetic Testing in Oncology: Specific Tests' (L39365) local coverage determination (LCD). The LCD released on 9 January 2025 threatens to end Medicare coverage of Cxbladder on 24 April 2025.

Under current legislation, MACs are required to consider consensus statements and/or guidelines in determining coverage. Pacific Edge will inform Novitas of the new guideline and expects to use the AUA guideline and the evidence on which it is based for a formal reconsideration of the LCD.

Pacific Edge Chief Medical Officer Dr Tamer Aboushwareb said: "The inclusion of Cxbladder Triage in the AUA guideline for the management of microhematuria is a significant milestone for Pacific Edge. While the guideline does not mandate the use of Cxbladder Triage, they are authoritative, reinforcing best practice within the urological industry and supporting greater adoption of Cxbladder in hematuria evaluation.

"Cxbladder is the only test supported by a Grade A evidence from the AUA Guideline panel and the update reflects the strength of the evidence supporting Triage and will help to reduce the burden of unnecessary cystoscopies in patients of lower risk, resulting in less patient discomfort and less morbidity, and improved access to care by reducing wait times," Dr Aboushwareb said.

Pacific Edge Chief Executive Dr Peter Meintjes said: "We are very pleased that Cxbladder Triage has been acknowledged with its inclusion in the AUA guideline. This is an outstanding result for patients across the US, and a reflection of the role genomic tests now play in the standard of care for bladder cancer patients as they have already done for prostate, breast, colon and other cancers.

"Importantly, while the AUA Guideline language is currently focused on Cxbladder Triage for intermediate-risk microhematuria patients, we now have a strong foundation for the future inclusion of Cxbladder Triage Plus for a wider range of patient types given its superior performance characteristics6. Additionally, any competing product or service will have to complete their own randomized clinical trial to establish the same Grade A evidence, fortifying our first-mover advantage."

Dr Meintjes concluded: "The acknowledgement of Cxbladder in the AUA guideline reinforces how we create value for investors, i.e. with the continued commitment to generating the highest quality clinical evidence within a framework of AV, CV and CU, and with the appropriate end points and statistically significant sample sizes. Importantly, creating value for investors through evidence development is a core expertise that Pacific Edge can repeat for Cxbladder Triage Plus, for Monitor Plus and products beyond bladder cancer."

[Pierre]

The AUA guidelines inclusion certainly gives Novitas a face-saving way of reversing their LCD position.

Let's hope they act quickly and make the call before the April implementation date of their current decision.

Then it definitely will be onwards and upwards for PEB as both the AUA inclusion and a positive LCD outcome will be influential in many other countries as well as in the US.

[Greekwatchdog]

Well thats was a good day not withstanding Novitas pending decision. Timing was pretty good by AUA. I would think if Novitas say no again PEB would have good grounds to go via the courts..

This should open up alot more doors in the US now, I am interested in where John Hopkins is with their analysis since they started trialing this late 2019, mind you Covid hit so they could have slowed things down.

Anyway congrats to those fellow shareholders that sucked the last 2.5 years up

[LoungeLizard]

Email from PEB today. More evidence of strong indiustry support and further undermining Novitas decision

Dear Shareholder,

The inclusion of Cxbladder Triage in a February 2025 amendment to the American Urology Association (AUA) Microhematuria Guideline is set to headline a symposium at the Annual Meeting of the Southeastern Section of the AUA (SESAUA) to be held 12-15 March in Nashville, Tennessee.
 
The SESAUA Meeting is attended by several hundred urologists and is the first opportunity for Pacific Edge to promote Cxbladder Triage since its inclusion in the AUA Microhematuria Guideline. Cxbladder Triage will headline a symposium focused on the use of Triage to risk stratify patients with microhematuria in line with the new AUA guideline2.
 
In a major amendment to the 2020 microhematuria guideline, the updated guideline now incorporates language for the use of urine-based biomarkers to help avoid cystoscopy in intermediate-risk patients3. In support of this, the guideline specifically mentions Cxbladder Triage as the only urine-based biomarker test underpinned by 'Grade A' evidence linked to a randomized controlled trial - the STRATA4 Study. The STRATA study demonstrated a first for any urine biomarker, that Cxbladder Triage could safely and effectively reduce cystoscopies by as much as 59% without missing tumors.
 
With the guideline inclusion and symposium providing a focal point for discussion at the event, Pacific Edge will be hosting a booth in the main hall alongside a range of other targeted activities through which the team will engage with customers and other attendees.
 
The SESAUA symposium will be presented by Dr Zachary Klaassen, Urologic Oncologist and Associate Professor of Urology; Wellstar MCG Health and the Georgia Cancer Center.
12:15 to 1:15 PM, Thursday 13 March (CDT): Cxbladder Triage: Risk Stratification for Patients with Microhematuria (Grand Hyatt, Summit Ballroom AB)
Pacific Edge Chief Executive Dr Peter Meintjes said: "We are excited by the opportunity to promote Cxbladder Triage to urological teams from across the Southeastern Region and the wider US with the support of AUA guideline inclusion language. Importantly the updated recommendation will benefit patients, reducing the burden of unnecessary cystoscopies for those with lower risk, resulting in less patient discomfort and morbidity. Those at higher risk will benefit from improved access to care through reduced waiting times.
 
"While the guideline does not mandate the use of Cxbladder Triage, it is authoritative, reinforcing best practice within the urological industry. As a consequence, Pacific Edge anticipates an uplift in demand for Cxbladder tests as more clinicians begin to observe this new recommendation and incorporate the tests into care pathways."

[raW tent Buffer]

This is cool but what is happening with Novitas? Are PEB taking legal action? I don't find the previous update of 'ongoing dialogue' particularly reassuring given Novitas have so far ignored what appears to be common sense. Medicare coverage gone in 6 weeks unless something happens prior...

[LoungeLizard]

This is cool but what is happening with Novitas? Are PEB taking legal action? I don't find the previous update of 'ongoing dialogue' particularly reassuring given Novitas have so far ignored what appears to be common sense. Medicare coverage gone in 6 weeks unless something happens prior...

I suspect there is a lot of things going on behind the scenes with Novitas, the AUA and PEB, that we are not privy too.
 You're right though, that Novitas seem to be a law unto themselves and ignore medical evidence and industry submissions. No-one really knows which way they are going to jump.

I would say though, that if they do rescind coverage in 6 weeks, then that is when PEB will launch legal action. PEB have already put out into the public domain that a legal challenge is one of their options and Novita's legal team must be aware - and should be advising Management - that they have a very strong chance of losing in court if it comes to that. But neither PEB or shareholders want to go through a messy, long and expensive legal challenge so that's why I think they are holding off until the final decision comes through.

Not long now!

[raW tent Buffer]

Thanks LL, do you have any idea what would happen with coverage whilst legal proceedings were ongoing?

[LoungeLizard]

Thanks LL, do you have any idea what would happen with coverage whilst legal proceedings were ongoing?

Very good point - answer is, don't know. I think they would apply for an interim injunction on the decision ( ie for the affect of that decision to be suspended and coverage to continue until the court decides) but that's one for the legal boffins out there. Anyone?

[Greekwatchdog]

Posted by Psychic on the other site..
4 weeks to go before Novitas decide as the evidence continues to come in

Independent study Monitor and Triage just published:

https://www.tandfonline.com/doi/pdf/10.2147/RRU.S516994


Results: A combined 236 patients were recruited (CxbT = 134, CxbM = 102) with results showing excellent negative predictive value
of 96.43% and 95.16%, respectively. A key result showed that CxbT in combination with upper tract imaging done as routine was able
to rule out UC completely in low-risk patients.

Conclusion: We have validated the use of Cxbladder as an adjunct in the investigation and surveillance of UC. It is a non-invasive,
accurate and reproducible test that can aid in ruling out UC, specifically for low-risk patients

[Left Field]

Mixed update from PEB..... USA news of increased tests in 4 QTR encouraging.... but overall  tests down for the year?

https://www.nzx.com/announcements/449639

[winner (n)]

Mixed update from PEB..... USA news encouraging.... but overall tests down?

https://www.nzx.com/announcements/449639

But headline says UP

Cxbladder Volumes Rise and Key Metrics Improve

[Pierre]

Mixed update from PEB..... USA news of increased tests in 4 QTR encouraging.... but overall  tests down for the year?

It's  the US market - and the Novitas decision - that really matters. Fingers crossed for some positive news this month on the LCD outcome.

If reimbursement continues past 24 April, then it's up, up and away.

[Pierre]

But headline says UP

Cxbladder Volumes Rise and Key Metrics Improve

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

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