Pacific Edge Gains US Medicare Approval, Stock Jumps 17% in Two Days
The cancer diagnostics firm now faces an addressable market worth over $1 billion annually, with reimbursement rates set between $1,057 and $1,328 per test.
By Austin Reed ·
Dunedin-based cancer diagnostics company Pacific Edge saw its shares climb 8% on Friday after announcing that its urine-based cancer tests received Medicare coverage in the United States. This gain follows a 9% increase in share price on Thursday, marking a rapid surge in investor confidence tied directly to the new reimbursement policy.
The Centers for Medicare and Medicaid Services approved the Triage and Triage Plus tests for reimbursement. The coverage rate is set between US$1,057 and US$1,328, which converts to approximately NZ$1,888 and NZ$2,372 respectively. Pacific Edge estimates this creates about 1.14 million eligible testing opportunities per year, representing an annual market value exceeding US$1 billion.
The Cxbladder tests utilize a non-invasive urine sample to evaluate bladder cancer risk. This allows physicians to determine if a cystoscopy is necessary for patients with hematuria. Previously, uncertainty over reimbursement made some doctors hesitant to order these tests. The new Medicare listing removes that financial barrier, providing clear guidance on which patients qualify for coverage.
Chief Executive Peter Meintjes described the decision as a major milestone for the company, its patients, and urologists. He stated that the policy confirms Pacific Edge as the market leader because only Triage and Triage Plus are covered under the new rules. Meintjes noted that competing tests and generic billing codes are excluded, giving the firm a distinct competitive edge in the US market.
The company already has a foothold in the US, with more than 5,000 urologists having ordered over 130,000 Cxbladder tests. Medicare covers more than 71 million people in the country. Pacific Edge believes this government coverage will also facilitate deals with commercial insurers, which serve approximately 223 million additional patients. The firm is currently investing in its US commercial team and digital infrastructure to capture this expanded demand.
The new coverage policy officially takes effect on December 20. Until that date, the company will continue to leverage its existing relationships with urologists. The immediate financial impact is already visible in the stock market, where the two-day rally reflects the removal of the reimbursement obstacle that had previously limited adoption among US practitioners.
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