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Pacific Edge has focused on securing Medicare coverage for Cxbladder though navigating short term operational challenges. Their latest update shows progress on both regulatory and clinical fronts.
Pacific Edge Limited (ASX: PEB)Β
reported its Q3 FY26 update highlighting regulatory progress and operational performance. The company is preparing for Novitasβ Contractor Advisory Committee meeting on 20 February, an important step before a potential new or revised Local Coverage Determination (LCD). This process is central to restoring long term Medicare reimbursement for Cxbladder.
A major positive development is the acceptance of Kaiser Permanenteβs real world evidence study on Cxbladder Triage in Urology Practice. The study, previously previewed at the American Urological Association meeting, strengthens the clinical case and may support discussions at the upcoming CAC meeting. Also, Avalon Healthcare Systems has endorsed Cxbladder Triage as meeting coverage criteria, adding further third-party validation.
On reimbursement arguments, PEB has secured its first Medicare appeal hearing date for denied Cxbladder Triage claims, scheduled shortly after the CAC meeting. This marks progress in challenging coverage changes under the Genetic Testing for Oncology LCD.
Total laboratory throughput declined 13.4% to 5,446 tests in Q3. US volumes dropped 19.5%, reflecting reimbursement uncertainty and seasonal slowdown and APAC volumes increased 9.7% driven by commercial demand. Despite short-term pressure, PEB believes it is strategically positioned for a more stable Medicare framework in 2026.
(Source: Company Report)
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