Craif, a Nagoya University spinout, raised $33 million in a Series D round and is scaling toward US clinical evaluation of its urine-based pancreatic cancer test. The company plans to expand its San Diego lab ahead of a planned clinical trial and prepare an AI-enabled pancreatic cancer risk device for regulatory submission in Japan. Craif’s miSignal Dx uses microRNA signals from exosomes within urine to generate a pancreatic cancer risk score, and it is designed to run alongside the company’s miSignal Scan multicancer early detection (MCED) test. Craif said it expects to be ready for a PMDA submission by year-end or early next year, while working toward CLIA certification in the US. In the US, Craif said it intends to recruit approximately 500 higher-risk participants identified by anatomical abnormalities linked to pancreatic cancer and target an interim readout in 12 to 18 months, with full study completion in about 24 to 26 months. The financing and US timeline put pressure on performance claims typical of early-detection assays, where specificity and clinical utility are tightly scrutinized by providers and payers.