Photocure agreed to acquire Vesica Health for $30.5 million, adding urine-based molecular diagnostics to its bladder cancer portfolio. The deal includes cash and stock payments, with milestone-linked consideration tied to Medicare reimbursement. Vesica’s AssureMDx test uses methylation-specific PCR and next-generation sequencing to analyze six epigenetic and somatic biomarkers from urine, designed for hematuria risk stratification and earlier bladder cancer detection. Photocure said the test has been validated in prospective multicenter studies, reporting 96% sensitivity and a 99.7% negative predictive value, and that it received FDA Breakthrough Device Designation and an American Medical Association PLA code. The acquisition aims to accelerate commercialization using Photocure’s urology footprint and payor relationships, potentially shifting earlier decision-making in microhematuria pathways away from reflex cystoscopy toward molecular triage.
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