Japanese startup Craif has raised $22 million to expand its AI-powered, urine-based cancer detection tool into the U.S., leveraging microRNA biomarkers and noninvasive testing to offer earlier, easier and more scalable diagnostics. (Source: Image by RR)

Noninvasive Urine Tests Aim to Improve Early Cancer Detection Rates

Craif, a Japanese biotech startup founded in 2018 and spun out from Nagoya University, is using AI and microRNA (miRNA) biomarkers to develop a noninvasive early cancer detection tool. With global cancer rates rising rapidly—nearly 20 million new cases were reported in 2022 and projections estimate 29.9 million annually by 2040—Craif aims to revolutionize early screening with its urine-based test. The company, according to a story in techcrunch.com, just raised $22 million in Series C funding, bringing its total to $57 million and earning a valuation near $100 million.

Craif’s flagship product, miSignal, detects the risk of seven cancers using urinary miRNA, offering a pain-free alternative to traditional, often invasive, diagnostics like blood tests. Co-founder and CEO Ryuichi Onose, motivated by personal experiences with cancer in his family, built the company with co-founder Takao Yasui, who developed the core biomarker technology. Unlike many competitors who use cell-free DNA, Craif uses miRNA, which has gained scientific recognition for its early signaling of cancer activity.

The company has already achieved success in Japan, partnering with over 1,000 medical institutions and 600 pharmacies to reach more than 20,000 users. Craif’s diverse revenue model includes single-test sales and popular subscription options. In 2024, it earned $5 million in revenue and aims to triple that to $15 million by year-end. The company is expanding miSignal to detect ten cancers and plans to apply its technology to non-cancer diseases like dementia.

To scale internationally, Craif is entering the U.S. market, where it has set up R&D operations in Irvine, California, and plans a business office in San Diego. The new funds will support clinical trials for FDA approval, targeting a 2029 timeline. Craif has begun gathering pancreatic cancer samples through partnerships with 30 medical institutions across 15 states, positioning itself as a major player in the race for noninvasive, AI-powered early cancer diagnostics.

read more at techcrunch.com