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.
CMS to set the AssureMDx rate before year-end for January 1, 2027
Medicare pricing and coverage run on separate tracks. CMS expects to make a final pricing determination before year-end 2026, and the rate would take effect January 1, 2027. Photocure described discussions with pricing authorities as encouraging.
Novitas acknowledged favorable diagnostic performance of AssureMDx
In the largest prospective study, AssureMDx could spare 89% of patients with microhematuria from cystoscopy, and all upper-tract urothelial cancers in the study were detected. That evidence contributed to the test's inclusion in the 2025 AUA/SUFU microhematuria guidelines. The test received FDA Breakthrough Device Designation in February 2026. Novitas acknowledged the favorable diagnostic performance and potential clinical utility of the existing evidence.
Two randomized trials target the evidence gap
The SeARCH study is an investigator-initiated randomized controlled trial run by Erasmus University Medical Center in the Netherlands. It enrolls approximately 1,100 patients with microhematuria and is supported by a Dutch Cancer Society grant. It began before the Vesica Health acquisition, and Photocure participates as industry sponsor and collaborator through Vesica Health.
Photocure is also finalizing the protocol for PATHWAY, a U.S. randomized controlled clinical utility study in the intended-use microhematuria population. The company plans to re-engage the Novitas medical review team on evidence expectations and its clinical development approach before the study starts. Together, the two trials are intended to support future Medicare coverage reconsideration and potential guideline updates.
Dan Schneider, President and CEO, said the company remains focused on generating the additional evidence needed for Medicare coverage.
Commercial payers remain open; first revenue still expected in 2027
The published LCD does not preclude commercialization through commercial payer and other reimbursement channels, which Photocure will continue to pursue. The company continues to expect initial AssureMDx revenue in 2027.