Pacific Edge Wins Two-Month Medicare Coverage Delay for Genetic Cancer Tests

Medicare Coverage Delay

Pacific Edge, a global leader in cancer diagnostics headquartered in Dunedin, New Zealand, has announced a notable extension to the effective date of the Medicare Local Coverage Determination (LCD) for its genetic testing in oncology. Originally set to take effect on February 23, 2025, the LCD’s implementation has now been postponed until April 24, 2025. This two-month delay was revealed following an unexpected, off-schedule update to the Medicare Coverage Database.

Regulatory Engagement and Implications

The extension appears to be the result of Pacific Edge’s proactive advocacy efforts. The company engaged with multiple US health authorities, including Novitas (the Medicare Administrative Contractor responsible for Pacific Edge’s US laboratory), GuideWell (Novitas’ parent company), the Centers for Medicare & Medicaid Services (CMS), and the Department of Health and Human Services’ Office of the General Counsel. Pacific Edge also reached out to incoming political leadership, seeking revision or withdrawal of the LCD. While the update lacks an official explanation, the timing strongly suggests these efforts influenced the delay.

Strategic Significance of the Cxbladder Test

Pacific Edge’s flagship product, Cxbladder, is a urine-based genomic biomarker test designed for the detection and surveillance of bladder cancer. With over 14 years of clinical evidence and more than 20 peer-reviewed publications supporting its use, Cxbladder has been adopted by over 4,400 US urologists and used in the management of more than 100,000 patients. The test’s availability through CLIA-certified laboratories in both New Zealand and the US underscores its global reach and importance.

Market and Patient Impact

The Medicare LCD governs reimbursement policies that directly affect the accessibility and adoption of genetic testing services like Cxbladder in the US market. The delay in the LCD’s effective date could provide Pacific Edge with additional time to influence policy details, potentially securing more favorable coverage terms. For patients, this extension may mean continued access to Cxbladder under existing Medicare arrangements for a longer period before any new coverage rules take effect.

Looking Ahead

Pacific Edge has committed to keeping shareholders informed as further information becomes available. The company’s ongoing dialogue with regulatory bodies and political stakeholders will be critical to watch, as the final terms of the LCD could significantly impact Pacific Edge’s US market strategy and revenue trajectory.