US Medicare reimburses Pacific Edge bladder cancer tests at up to $1,328

Pacific Edge shares climbed 8% in trading on Friday, following a 9% increase on Thursday, after the Dunedin-based diagnostics firm confirmed its bladder cancer urine tests are now reimbursed by US Medicare. The federal program will cover the company's Triage and Triage Plus assays at rates ranging from $1,057 to $1,328 per test, a decision that took effect on December 20.

The coverage applies to patients presenting with hematuria, providing urologists with a non-invasive alternative to cystoscopy for assessing bladder cancer risk. Pacific Edge estimates the policy opens up approximately 1.14 million eligible testing opportunities annually. The company values this addressable market at well over $1 billion per year, though it expects to capture only a portion of the total revenue.

Peter Meintjes, chief executive of Pacific Edge, described the Local Coverage Determination as a milestone for patients and clinicians. He noted that the policy explicitly identifies which hematuria patients qualify for reimbursement of Triage and Triage Plus. "The LCD confirms Pacific Edge as the market leader, with only Triage and Triage Plus tests covered under the policy," Meintjes said.

The new policy creates a distinct competitive advantage because competing tests and generic billing codes are not covered under the current Medicare rules. This clarity addresses a previous reimbursement obstacle that had made some physicians hesitant to order the tests. More than 5,000 US urologists have already ordered over 130,000 Cxbladder tests, and the firm believes the federal backing will accelerate adoption among specialists.

Medicare currently insures more than 71 million Americans. Pacific Edge indicated that the federal approval could also serve as a benchmark for commercial insurers, which collectively cover approximately 223 million people. The company is preparing for this expansion by making selective investments in its US commercial team and digital technology infrastructure.

The reimbursement structure ensures that only Pacific Edge's specific assays are billable under the new policy. This exclusivity is intended to streamline decision-making for urologists who must determine whether a patient requires an invasive procedure. The company's tests utilize a urine sample to detect cancer markers, offering a less burdensome option for initial screening.

The stock movement reflects investor reaction to the confirmed market access. The 8% gain on Friday brings the total two-day rise to 17%. The decision solidifies the company's position in a market where reimbursement clarity is a primary driver for physician ordering behavior.