Photocure Keeps 2028 Medicare Timeline for AssureMDx After LCD Miss
OSLO, Norway – November 09, 2026 -- Photocure ASA (OSE: PHO) said the Medicare coverage timeline for its AssureMDx bladder cancer test remains in line with its original acquisition assumptions, after the test was left out of a newly published Novitas Local Coverage Determination (LCD) dated November 6, 2026. Pricing talks, however, point to a potential reimbursement level "meaningfully above" the assumptions in the company's initial underwriting.
Photocure planned for 2028 Medicare coverage when it bought Vesica Health
When Photocure acquired Vesica Health on June 4, 2026, its planning assumption was Medicare coverage in 2028, following submission of additional clinical evidence. A proposed Novitas LCD in May 2026 had raised the prospect of an earlier decision. The final LCD covers urine-based biomarkers in patients with microhematuria but does not include AssureMDx. It identifies additional clinical evidence needed for future reconsideration.