Craif, a bio-AI venture spun out of Nagoya University, is drafting a Japanese regulatory submission for a urine-based, AI-driven pancreatic cancer test that, if approved, would be the first of its kind worldwide. The Tokyo-headquartered firm is also strategically preparing to introduce its flagship non-invasive test, miSignal, in the U.S. after recently closing a $33 million Series D round.
A New Diagnostic Approach
“It would be a first,” Craif CEO and co-founder Ryuichi Onose said of the planned regulatory filing in Japan. “To our knowledge, there is currently no approved urine-based test for pancreatic cancer anywhere in the world, which means this would establish an entirely new category of test,” he told MobiHealth News.
Onose explained that pancreatic cancer is considered one of the deadliest cancers because it is “so rarely detected early.” He added that a non-invasive test that can be performed at home, and that the company expects to outperform currently approved blood-based tests, has the potential to change who gets diagnosed in time.
In a study published in eClinicalMedicine, miSignal’s underlying AI model detected pancreatic cancer across disease stages, including at early stages, by analyzing microRNA in urine. The test demonstrated sensitivity and specificity exceeding 90%, outperforming conventional blood-based testing.
Global Expansion and Funding
miSignal is offered at more than 2,500 medical institutions and 4,500 pharmacies across Japan. Founded in 2018, Craif is building one of the world’s largest urine datasets. The company is developing a urine analysis platform for the early detection of multiple diseases, initially focusing on cancer. Its latest funding round brought its total funding raised to about $88 million.
The company also announced plans to expand R&D at its newly opened laboratory in San Diego, including a prospective clinical study. Craif recently appointed Dr. Nicholas Bevins as chief medical officer. He previously held similar roles at several biotechnology and diagnostics companies and will lead its clinical development strategy and build the evidence needed to meet regulatory and reimbursement requirements.
Strategic Partnerships in the US
Craif established its US subsidiary in 2022 and is now in advanced talks with 30 medical institutions across 15 states about potential partnerships.
The broader trend in AI-powered cancer diagnostics includes developments from other companies. Fujitsu, a Japanese firm, is developing an AI-based tool for early pancreatic cancer detection from CT scans, partnering with Southern Tohoku General Hospital in 2022. Meanwhile, Taiwan’s National Taiwan University Hospital launched PANCREASaver, an AI-powered diagnostic imaging service using deep learning to analyze CT scans, which received US FDA breakthrough device designation and demonstrated 80% sensitivity in detecting early-stage pancreatic tumors.
