Craif Raises $33 Million Series D to Bring Its Urine microRNA Cancer Test to the US and File a Pancreatic Cancer Diagnostic in Japan

How the test reads urine

Craif isolates exosomes from urine and sequences the microRNA they carry, then applies a machine-learning classifier trained, by the company's description, on tens of thousands of samples. The company's technology page says that as of April 2025 the miSignal Scan algorithm covers 10 cancer types: esophageal, gastric, pancreatic, lung, colorectal, ovarian, breast, kidney, bladder and prostate. For early-stage pancreatic cancer Craif claims 93% sensitivity and 93% specificity "as published in a peer-reviewed scientific journal"; the page does not name the journal, the cohort size or the stage mix behind those figures, and the release describes only "two independent publications demonstrating the early and accurate detection of pancreatic cancer" among more than 85 papers and presentations. Those numbers should be read as company-reported until the underlying studies are checked.

miSignal Scan is sold in Japan as a cancer-risk test and is not available in the US. The product Craif is taking to regulators is different: a pancreatic cancer decision-support device that scores urinary microRNA expression and returns a positive or negative result for people with symptoms or risk factors, which the company's trial definitions list as type 2 diabetes, chronic pancreatitis, family history, IPMN, pancreatic cysts or ductal dilation. A multicenter Japanese trial of that device began in 2024.

A pathologist to build the US case

Dr. Bevins trained in biochemistry at Columbia, took his MD and a neuroscience PhD at UC San Diego, and completed a clinical pathology residency, and he has served as both CMO and CLIA laboratory director at several diagnostics companies. Craif's release makes the reason for the hire explicit: a laboratory-developed test in the US needs a CLIA-certified laboratory under a qualified director, and Bevins supplies that qualification along with responsibility for clinical and regulatory strategy. "I joined Craif because the company has built a differentiated platform, generated an extraordinary body of clinical evidence in Japan, and is committed to advancing science through rigorous data rather than hype," he said.

Ryuichi Onose, the CEO, relocated to San Diego this year. "I moved to San Diego to build our U.S. business myself, because the United States is the hardest and most important market to prove this technology," he said, adding that "the earliest signals of many diseases show up in urine, and reading them is what Craif is really about. Cancer is the first step." Chief financial officer Takeo Mukai, formerly of Medtronic, was hired locally. On the investor side, Masataka Nonaka, president of Tauns Laboratories, said his company expects the funding "to move both miSignal and the pancreatic cancer SaMD program now in development closer to real-world clinical use."

Craif's own evidence base in Japan includes a 100-resident prospective screening study in Iwanai and Yoichi, Hokkaido, with Hokkaido University Hospital and Iwanai Kyokai Hospital, in which one participant flagged by miSignal Scan had a stage 0 lung cancer resected, and a 100-resident pancreatic cancer pilot in the Tokai region with Nagoya University and Fujita Health University.

Why This Matters to the APO|APE Reader

Craif has picked pancreatic cancer in symptomatic and high-risk patients as its first US indication, and its own materials position the device beside tumor marker tests and abdominal ultrasound as a decision aid for further workup, which is the framing a laboratory director would validate it under: a rule-in or rule-out tool in a defined referral population that already includes diabetes, chronic pancreatitis and cystic lesions. No US performance data exist yet, so the San Diego prospective study funded by this round is where the first American sensitivity and specificity estimates will come from, and the 93% figures reported from Japan are the benchmark they will be measured against.