Norwegian bladder cancer diagnostics company Photocure has completed the acquisition of US-based diagnostics firm Vesica Health, expanding its capabilities in noninvasive molecular testing for the early detection of bladder cancer.
The transaction, valued at USD 30.5 million in cash and stock, includes a USD 3 million equity investment made during the first quarter of 2026.
The acquisition strengthens Photocure’s precision diagnostics portfolio by adding Vesica Health’s urine-based molecular diagnostic technology.
Vesica Health’s lead product, AssureMDx, is a multi-omic urine biomarker test designed to support risk stratification in patients with hematuria (blood in the urine), who may be at increased risk of bladder cancer. The assay combines six epigenetic and somatic biomarkers to guide urologic evaluation through a noninvasive urine-based testing approach.
Dan Schneider, Chief Executive Officer of Photocure, said, “This transaction represents a significant step forward in our strategy to build a comprehensive bladder cancer platform.”
“By combining Vesica Health’s best-in-class hematuria early detection capabilities with our established diagnostic solution and commercial infrastructure, we are well positioned to accelerate growth and deliver improved outcomes for patients with urological cancers,” he added.
AssureMDx has been validated in prospective multicenter clinical studies, including a large study involving 838 hematuria patients. The study demonstrated 96 per cent sensitivity, a 99.7 per cent negative predictive value (NPV), and an area under the curve (AUC) score of 0.96 for bladder cancer detection.
AssureMDx’s commercialization is expected to be significantly accelerated through Photocure’s established bladder cancer leadership, commercial infrastructure, urology footprint, and payer relationships. For Photocure, the addition of AssureMDx expands its reach into the large and rapidly growing hematuria evaluation market.
Christopher Thibodeau, CEO of Vesica Health, said, “Noninvasive genomic testing and blue light cystoscopy are highly complementary technologies within the bladder cancer care continuum, and bringing these approaches together through Photocure’s established platform has the potential to accelerate clinical adoption, support more informed clinical decision-making, and expand access to advanced noninvasive bladder cancer diagnostics.”
Dr. Sam S. Chang, Professor of Urology and Chief Surgical Officer at Vanderbilt-Ingram Cancer Center, said combining noninvasive molecular tests such as AssureMDx with advanced visualization technologies like Blue Light Cystoscopy could help improve clinical decision-making and patient management throughout the bladder cancer care pathway.
AssureMDx was included in the American Urological Association (AUA) guidelines for microhematuria evaluation in September 2025, received an American Medical Association (AMA) Proprietary Laboratory Analyses (PLA) code effective January 2026, and secured US Food and Drug Administration (FDA) Breakthrough Device Designation in February 2026.
