Pacific Edge secures vital Medicare draft coverage

Pacific Edge (ASX:PEB) has announced that Novitas has published a draft Local Coverage Determination and associated Local Coverage Article that includes positive coverage for its Cxbladder Triage and Triage Plus tests.

The draft LCD, titled ‘Urine-based Biomarkers in Patients with Microhaematuria' (DL40378), marks the first time haematuria evaluation has been established as a covered Medicare benefit, distinguishing this patient population from those under existing non-coverage policies for oncology genetic testing.

The rationale provided by Novitas highlights the clinical necessity of multi-analytes in urine-based biomarkers in risk-stratifying intermediate-risk patients with microhaematuria who are considering deferring more invasive cystoscopy procedures.

By providing explicit coding guidance for Cxbladder Triage (0363U) and Triage Plus (0420U), the draft policy effectively creates a competitive "moat" around Pacific Edge’s microhaematuria business, as no other UBBs were included for reimbursement in the associated draft article.

Pacific Edge CEO Dr Peter Meintjes hailed the decision as a reflection of the substantial clinical evidence developed by the company and the urgent needs identified by expert panels.

The decision follows a focused reconsideration process involving input from the American Urological Association and other clinical stakeholders during a contractor advisory committee meeting held earlier in 2026.