Pacific Edge Limited (ASX:PEB)

Pacific Edge Limited, a cancer diagnostics company, announced that the US Centers for Medicare & Medicaid Services (CMS) has recommended a final 'Gapfill' price of US$1,328.32 for their Cxbladder Triage Plus test, an increase from the previously proposed draft price of US$1,018. This price will determine the reimbursement amount for Medicare and Medicare Advantage patients, contingent upon coverage by Pacific Edge's Medicare Administrative Contractor, Novitas. Although currently listed as non-covered by Novitas, Pacific Edge plans to submit a reconsideration request following the peer review publication of the DRIVE Study. Hematuria evaluation tests account for approximately 83% of the company's US laboratory throughput. The higher CMS price reflects the test's advanced multimodal approach, which combines DNA and RNA analysis to enhance performance and broaden patient application. The final price is expected to take effect on 1 January 2026, pending a 60-day notice and comment period.