Photocure, the diagnostics company based in Oslo, Norway, said it continues to plan for Medicare coverage of its AssureMDx bladder-cancer test in 2028 after the test was not included in a newly published Novitas coverage policy. The timetable is the company’s planning assumption, not a Medicare commitment.
In a November 9 update, Photocure said an earlier draft policy had opened the possibility of faster coverage. It now expects the process to remain aligned with the assumptions it used when it acquired test developer Vesica Health on June 4, 2026.
The final Novitas Local Coverage Determination, L40378, published in Medicare’s coverage database, is marked for services on or after December 20, 2026. Its notice period began November 5. The policy addresses urine-based biomarkers for patients with microhematuria, or blood in the urine detectable at a microscopic level, under defined patient-selection and evidence requirements.
AssureMDx is a laboratory-developed urine test that examines molecular markers associated with bladder cancer. The commercial aim is to help doctors decide which patients need further investigation. That is different from proving that a test-guided approach can safely change care in the specific population covered by the policy.
The final LCD discusses AssureMDx’s favorable diagnostic performance in published studies, but also identifies important gaps. Novitas said it found no published analytical validation of the current commercially available assay, no prospective study of a test-guided management strategy and no validation study confined to patients with microhematuria.
The policy also raises concerns about studies that combined patients with visible and microscopic blood in the urine, or enrolled a higher proportion of people with cancer than would be seen in routine microhematuria evaluations. Those differences matter because results from a study population may not carry over directly to the people for whom coverage is being considered.
For Photocure, the issue is therefore more than obtaining a price for the test. A payment rate and coverage answer different questions: how much a payer would pay and whether it will pay in the circumstances defined by its policy. This update does not establish an AssureMDx Medicare coverage approval or a guaranteed date for one.
The company said additional evidence is being developed. SeARCH, an investigator-initiated randomized study at Erasmus University Medical Center in the Netherlands, is evaluating whether AssureMDx can guide diagnostic decisions and reduce unnecessary cystoscopies while maintaining patient safety. Photocure supports the work through Vesica Health. A cystoscopy is an examination of the bladder using a scope.
Photocure is also finalizing the protocol for PATHWAY, a planned U.S. randomized clinical-utility study, and intends to seek feedback from the Novitas medical review team before it begins. The announcement does not report results from either programme or confirm that the planned U.S. study has started.
Photocure said the policy does not prevent it from pursuing commercial insurers and other reimbursement channels, and it still expects initial AssureMDx revenue in 2027. That is a company forecast, not contracted revenue disclosed in the update. The outcome of the studies, the evidence needed for a future coverage reconsideration and the eventual coverage decision remain unresolved.
JBizNews Desk | Oslo, Norway
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