Photocure prepares US trial of AssureMDx to support Medicare coverage

• Photocure maintained its anticipated 2028 Medicare coverage timeline for AssureMDx following exclusion from Novitas’ November 6, 2026, coverage determination.
• The ongoing SeARCH trial and planned U.S. PATHWAY trial aim to generate clinical utility evidence for future Medicare coverage reconsideration.
• Previously published prospective findings showed AssureMDx could reduce unnecessary cystoscopies while detecting all upper-tract urothelial cancers in the largest study.
• CMS expects a final pricing decision before year-end 2026, effective January 1, 2027; reimbursement indications exceed initial acquisition assumptions.
• Initial AssureMDx revenue remains expected in 2027 through commercial payer and other reimbursement channels.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Photocure ASA published the original content used to generate this news brief via Cision (Ref. ID: 202611090200BITN____UKPR__EN_20261108-BIT-6365-0) on November 09, 2026, and is solely responsible for the information contained therein.