Company Interview / The small cap awaiting its Medicare moment

Key Points:

Pacific Edge (ASX:PEB) laboratory throughput dropped 13% in Q4DRIVE study offers new clinical validation for Triage Plus, supporting Medicare price upliftNon-invasive urine tests provide comfort and reliable results for bladder cancer diagnosis and surveillanceRegulatory process continues with an upcoming Medicare contractor advisory committee that may restore coverage

Pacific Edge (ASX:PEB), a bladder cancer diagnostics company, reports that laboratory throughput fell 13% in the December quarter, resulting in decreased revenue. However, CEO Peter Meintjes points to significant milestones, including the publication of the DRIVE study, which offers clinical validation for Triage Plus, the company’s next-generation product. Triage Plus received a positive pricing decision from Medicare, now valued at $1,328 per test—an upgrade from the previous $760. Meintjes highlights an accepted publication from Kaiser Permanente, providing real-world evidence and reinforcing the clinical utility of their diagnostic solution.

According to Meintjes, Pacific Edge’s key product, Bladder Triage, provides a non-invasive alternative for ruling out bladder cancer in patients with haematuria, boasting a 99.7% negative predictive value. Another diagnostic tool supports surveillance for patients previously diagnosed with bladder cancer, reducing the frequency of invasive procedures. These molecular diagnostic tests are widely used in the United States, supported by more than 5,000 urologists and over 130,000 tests to date.

Meintjes references regulatory challenges after a Medicare non-coverage determination in April, attributed to outdated evidence. He remains optimistic about a pivotal Medicare contractor advisory committee event in February, which he sees as a potential catalyst for policy reversal, supporting the future of Pacific Edge.