Highlights

  • Draft Medicare policy proposes reimbursement coverage for Cxbladder Triage and Triage Plus.
  • Pacific Edge says the proposal strengthens its position in non-invasive bladder cancer diagnostics.
  • Triage Plus reimbursement could significantly improve long-term profitability and commercial growth.

Overview

Pacific Edge Limited (NZX:PEB) has announced a major regulatory development after a draft Medicare Local Coverage Determination (LCD) proposed coverage for urine-based biomarker tests used in evaluating microhematuria patients. The draft policy specifically includes Cxbladder Triage and Cxbladder Triage Plus, marking the first time hematuria evaluation has been recognised as a covered Medicare benefit. The company believes the proposal represents a significant commercial opportunity, as it could support broader reimbursement access across both Medicare and private US healthcare insurers. Pacific Edge also highlighted that no competing urine-based biomarker tests were included in the draft coding guidance, potentially strengthening its market leadership position. The company expects the development to support future international adoption and long-term Revenue growth.

Why Is The Draft Medicare Coverage Important for Pacific Edge?

The proposed Medicare coverage is viewed as a major milestone because it formally recognises urine-based biomarker testing as part of microhematuria evaluation for eligible patients. Pacific Edge stated that the draft policy clearly separates microhematuria patients from broader oncology testing categories, creating a pathway for reimbursement of its Cxbladder products. The company believes this could accelerate adoption among urologists and healthcare providers across the United States. Since Medicare directly covers more than 66 million Americans, the proposal may also influence private insurers to adopt similar reimbursement policies, expanding the commercial potential of Pacific Edge’s diagnostic platform.

How Could Cxbladder Triage Plus Improve Pacific Edge’s Growth Outlook?

Pacific Edge believes inclusion of Cxbladder Triage Plus in the draft policy could materially improve its long-term financial outlook. The company said the newer test offers broader clinical Utility, works across a wider patient population, and delivers stronger economic benefits for healthcare systems. Importantly, the Medicare reimbursement rate for Triage Plus is substantially higher than older Cxbladder products, potentially supporting stronger profitability over time. Management also noted that its evidence-driven strategy continues to strengthen medical policy support and physician adoption. Alongside the Medicare development, Pacific Edge recently launched a retail share offer following a successful institutional Capital raising.