Craif raised $33 million in a Series D round and said it will accelerate its U.S. clinical trial plans for a urine-based pancreatic cancer assay built on microRNA analysis from exosomes. The company plans to expand its San Diego lab capacity, pursue CLIA certification, and recruit approximately 500 high-risk participants based on pancreatic anatomical risk factors. Craif’s device strategy pairs an expected pancreatic cancer risk score (miSignal Dx Pancreatic Cancer) with its multi-cancer early detection approach (miSignal Scan), with an interim clinical readout targeted 12 to 18 months after enrolling starts. The company also aims for reimbursement through CMS’s MolDx program after completing the planned study. The move highlights the continued shift in early oncology detection toward minimally invasive biofluid testing—and the operational focus needed to convert bench-grade assays into deployable clinical utility evidence.
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