Diagnostic company Photocure ASA (OSE: PHO) confirmed on Monday that the anticipated Medicare coverage timeline for its AssureMDx bladder cancer test remains aligned with its original acquisition assumptions, following a newly published coverage determination that did not include the test.

The Local Coverage Determination (LCD), published by Novitas on 6 November 2026, identifies additional clinical evidence required before coverage can be reconsidered. Photocure had previously anticipated Medicare coverage in 2028 following further clinical studies. Separately, the Centers for Medicare & Medicaid Services (CMS) is expected to make a final pricing determination before the end of 2026, with the resulting rate taking effect on 1 January 2027. Discussions with pricing authorities have indicated potential reimbursement above the assumptions made at acquisition.

Clinical evidence supporting AssureMDx includes a prospective study showing the potential to avoid cystoscopy in 89% of patients with microhaematuria while detecting all upper-tract urothelial cancers. The test is included in the 2025 American Urological Association and Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction guidelines and received FDA Breakthrough Device Designation in February 2026.

Further evidence is being generated through the SeARCH study, involving approximately 1,100 patients at Erasmus University Medical Center in the Netherlands, and PATHWAY, a planned US randomised controlled clinical utility study. Photocure intends to engage with Novitas to discuss evidence requirements and its clinical development programme.

The LCD does not prevent commercialisation through private insurers and other reimbursement channels. Photocure continues to expect initial AssureMDx revenue in 2027, consistent with its original acquisition assumptions. The non-invasive urine-based test is designed to aid early bladder cancer detection in patients presenting with haematuria and has demonstrated 96% sensitivity and a negative predictive value above 99% in clinical studies.