Expert panel backs Medicare coverage for Pacific Edge’s Cxbladder tests
A panel of eight medical specialists has expressed clear support for urine-based biomarkers in hematuria evaluation at a Contractor Advisory Committee (CAC) meeting organised by Novitas on 19 February 2026. The panel, comprising seven urologists and one pathologist, endorsed the clinical utility of Pacific Edge (ASX: PEB) Cxbladder tests, with evidence from the STRATA trial and Kaiser Study cited regularly throughout discussions.
CAC meetings are typically convened ahead of developing new or substantially revised Medicare policy. The weight of expert opinion expressed during the session represents a material step toward Pacific Edge Cxbladder Medicare Coverage, potentially unlocking the largest single payer market in the US for the company’s diagnostic tests. To date, more than 5,000 US urologists have ordered over 130,000 Cxbladder tests.
Chief Executive Dr Peter Meintjes said: “The clear sentiment from the panelists was that the sum of the published evidence available to Novitas, and the 2025 update to the AUA Microhematuria Guideline demonstrate that Cxbladder Triage and Triage Plus are medically reasonable and necessary under the Social Securities Act and given their demonstrated clinical utility, these tests would be appropriate for Medicare coverage.”
What is a Contractor Advisory Committee and why does it matter?
Novitas is the Medicare Administrative Contractor (MAC) with jurisdiction over Pacific Edge’s Pennsylvania laboratory operations. CAC meetings convene expert panels to provide clinical guidance before developing or revising Medicare Local Coverage Determinations (LCDs), which determine reimbursement policy for specific medical services.
The CAC process represents a formal step in the Medicare coverage pathway. Expert panel input feeds directly into LCD development, providing the clinical evidence foundation Novitas requires to justify coverage decisions. This removes a key uncertainty regarding whether Pacific Edge’s clinical evidence would be deemed sufficient to support Medicare reimbursement policy.
For investors, positive CAC sentiment materially reduces execution risk on the coverage pathway. The meeting outcomes suggest Novitas has sufficient clinical rationale to proceed with LCD development for urine-based biomarkers in hematuria evaluation.
Panel endorses expanded clinical use beyond current guidelines
The expert panel validated five specific clinical use cases for appropriately validated biomarkers in hematuria evaluation:
- Routine evaluation of all risk categories of hematuria to rule out bladder cancer
- Reflexive use after cystoscopy or cytology when those methods do not yield a result
- Limited adjunctive use alongside cystoscopy in situations where bladder visualisation is difficult due to inflammation, redness or blood, including some cases of gross hematuria
- Repeat use to rule out bladder cancer in patients with recurrent microhematuria of unknown origin
- Non-invasive alternative for patients resistant to undergoing cystoscopy
Dr John Sfakianos, Assistant Professor of Urology at the Ichan School of Medicine at Mount Sinai, said: “In the setting of a primary care office, family medicine office… something like Cxbladder that has a [high] Negative Predictive Value, I think could be useful because we could avoid referrals that are not necessary.”
Cxbladder Triage currently has analytical validation, clinical validation, clinical utility evidence, and inclusion in the American Urological Association (AUA) Guideline. Cxbladder Triage Plus has analytical and clinical validation, with AUA Guideline review pending.
Addressing the access gap in rural and underserved populations
Panelists emphasised the logistical and economic benefits of urine-based biomarkers, particularly when ordered from primary care settings. The discussion highlighted significant access challenges in the current diagnostic pathway for bladder cancer detection.
| Access Challenge | Biomarker Solution |
|---|---|
| 63% of rural counties lack urological care | Primary care ordering improves access |
| Only 13% of high-risk hematuria patients undergo cystoscopy | Non-invasive alternative increases diagnostic compliance |
| Women’s hematuria symptoms dismissed as UTI | Objective biomarker provides diagnostic pathway |
The panel noted that urine-based biomarkers enable prioritisation of higher-risk patient referrals to urologists, support earlier bladder cancer detection through increased compliance, and reduce the potential for more invasive muscle-invasive bladder cancer (MIBC) through timely diagnosis.
Expert panel makes direct appeal for Medicare reimbursement
In an unanticipated development, Professor Yair Lotan initiated a direct appeal to Novitas for Medicare reimbursement, with several other panelists following his lead. Professor Lotan, a principal investigator on Pacific Edge trials and member of the committee that wrote the 2025 AUA Microhematuria Guideline update, drew comparisons with prostate cancer markers to underscore the clinical significance of bladder cancer biomarkers.
Professor Yair Lotan, UT Southwestern
“We’re all used to using markers in prostate cancer for many years. There’s quite a plethora of them. If you look overall, they don’t perform as well as most of these urine markers, but they have been widely available… we are all fairly frustrated when we find this disease [bladder cancer] late and these patients don’t do well because this is a very aggressive cancer. So, I’m very hopeful that this [session] does lead to access to these markers, which I do think will help identify this disease early.”
Dr Jason Hafron, Chief Medical Officer at Michigan Institute of Urology, highlighted the critical need for non-invasive alternatives, noting that only 13% of patients with high-risk hematuria actually underwent cystoscopy. Professor Lotan added that the vast majority of patients with microhematuria in the US are not referred to urologists or receiving any evaluation whatsoever, resulting in delayed diagnoses.
At the meeting’s conclusion, Dr Megan Landsverk from Novitas stated that the feedback from panelists, alongside published evidence and the AUA Microhematuria Guideline, would inform the decision on whether LCD development is warranted.
Coverage timeline and what comes next
Pacific Edge does not control if or when Novitas will develop a new or substantially revised draft LCD supporting Cxbladder reimbursement. However, the company has provided estimated timelines based on the evidence framework and clinical need articulated by the expert panel.
Pacific Edge estimates that draft coverage could be published within approximately six months, with final-effective coverage following within a further approximately six months after the draft. Novitas has up to 12 months from published draft to finalise or retire any draft LCD. The contractor is expected to publish a full transcript of the meeting to its website in coming months.
If these timelines hold, final Pacific Edge Cxbladder Medicare Coverage could be in place by early 2027. This would transform US commercial economics by replacing the current case-by-case appeals process with systematic reimbursement, materially de-risking the revenue pathway for the company’s core diagnostic offering.
Building on momentum
Pacific Edge’s evidence portfolio extends to more than 30 peer-reviewed publications, supported by over 20 years of research into bladder cancer diagnostics. Cxbladder Triage is included in the AUA Microhematuria Guideline, providing clinical validation for its use in hematuria evaluation.
The company continues to generate clinical utility evidence through numerous ongoing and planned studies designed to drive increased adoption and improved patient health outcomes. Cxbladder is currently available in the US, Australasia, Israel, and markets throughout Asia and South America, with the US market representing the most significant commercial opportunity following potential Medicare coverage.
The CAC meeting outcomes position Pacific Edge to capitalise on the clinical need articulated by the expert panel, with systematic Medicare coverage representing the final regulatory milestone to unlock widespread adoption across primary care and urology settings in the United States.
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