Highlights

The final Local Coverage Determination for urine-based biomarkers in patients with microhematuria, identified as L40378, confirms coverage for Cxbladder Triage and Triage Plus.

Pacific Edge identifies approximately 1.14 million annual testing opportunities among intermediate-risk microhematuria patients.

Pacific Edge expects established coverage to remove logistical and reimbursement objections that may have discouraged some urologists from ordering tests.

The next dated milestone is 20 December 2026, when the final policy is scheduled to become effective.

Cancer diagnostics company Pacific Edge Limited (ASX:PEB) develops urine-based diagnostic tests through its Cxbladder portfolio. Access to medical testing in the United States depends not only on clinical use but also on whether a payer covers the service. Pacific Edge now has a defined Medicare policy for Cxbladder Triage and Triage Plus in patients with intermediate-risk microhematuria, with an implementation date and a clearly identified patient group.

A Coverage Decision with a Defined Scope

The final Local Coverage Determination for urine-based biomarkers in patients with microhematuria, identified as L40378, confirms coverage for Cxbladder Triage and Triage Plus. The policy establishes hematuria evaluation as a covered Medicare benefit and sets out the use of validated urine-based biomarkers in the intermediate-risk category. It is scheduled to take effect on 20 December 2026, 45 days after publication. The date matters because the coverage is prospective rather than already effective.

Two Tests Address an Identified Patient Group

Pacific Edge identifies approximately 1.14 million annual testing opportunities among intermediate-risk microhematuria patients. Cxbladder Triage and Triage Plus are the tests covered under the final determination, while competing tests and generic billing codes are not covered under that policy. The defined eligibility criteria establish the population relevant to this determination rather than providing unrestricted coverage for every patient presenting with blood in their urine.

Reimbursement Moves to the Foreground

The company expects established coverage to remove logistical and reimbursement objections that may have discouraged some urologists from ordering tests. Medicare reimbursement is therefore central to the commercial significance of the decision. The policy addresses coverage, but physician adoption, eligible patient identification, claim processing and actual testing volumes remain distinct from the publication of the coverage determination.

The Next Milestone Is Implementation

The next dated milestone is 20 December 2026, when the final policy is scheduled to become effective. Pacific Edge can use the intervening period to prepare for a covered testing pathway. The final LCD does not itself quantify future Revenue or guarantee that every eligible patient will receive a Cxbladder test. Future utilisation will depend on ordering decisions and practical implementation of the published Medicare coverage rules.