Pacific Edge wins US Medicare backing

Dunedin based diagnostics firm Pacific Edge saw its share price climb eight percent on Friday following the announcement that its urine tests for bladder cancer markers now qualify for US Medicare reimbursement.

The company developed Cxbladder tests, including Triage and Triage Plus, which analyze a non-invasive urine sample to help physicians evaluate a patient's risk of bladder cancer. The results assist doctors in determining whether a patient requires a cystoscopy, a more invasive procedure to examine the bladder lining.

Pacific Edge previously struggled with reimbursement hurdles in the US market. More than 5,000 US urologists had already ordered over 130,000 of these tests, but the lack of a clear Medicare billing code made some physicians hesitant to prescribe them. The new coverage policy resolves this barrier by providing specific guidance on eligible hematuria patients.

Chief Executive Peter Meintjes described the decision as a significant milestone for the company, patients, and urologists. He noted that the Local Coverage Determination confirms Pacific Edge as the market leader, as only the Triage and Triage Plus tests are covered under the new policy. Competing tests and generic billing codes remain excluded from reimbursement.

The financial terms of the coverage set reimbursement rates between US$1,057 and US$1,328. Pacific Edge estimates approximately 1.14 million testing opportunities exist annually within this eligible pool. The company projects that this addressable market is worth well over US$1 billion per year, though Pacific Edge expects to capture only a portion of that total.

Medicare covers more than 71 million people in the United States. Pacific Edge believes this government endorsement may also facilitate coverage from commercial insurers, which collectively serve about 223 million Americans. The new policy takes effect on December 20.

The company is currently making selective investments in its US commercial team and digital technology to prepare for the expanded market. Friday's eight percent rise in share value follows a nine percent gain recorded on Thursday.