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Craif, a Japanese biotech startup founded in 2018 as a spin-off from Nagoya University, has raised $22 million in a Series C funding round to expand its non-invasive early cancer detection technology. The funding, led by existing investor X&KSK and joined by Unreasonable Group, TAUNS Laboratories, Daiwa House Industry, and Aozora Bank Group, brings Craif’s total funding to $57 million, with a valuation nearing $100 million.
The company’s flagship product, miSignal, uses urinary microRNA (miRNA) analysis combined with AI to detect seven types of cancer—pancreatic, colorectal, lung, stomach, esophagus, breast, and ovarian—at early stages, such as Stage 1. Unlike traditional blood-based tests that rely on cell-free DNA (cfDNA), Craif’s approach leverages miRNA, which is actively secreted by early cancer cells and offers clearer biomarker signals due to urine’s lower impurity levels. This non-invasive method allows patients to collect samples at home, improving accessibility and reducing screening barriers.
Co-founder and CEO Ryuichi Onose, motivated by his grandparents’ cancer diagnoses, partnered with Nagoya University associate professor Takao Yasui to launch Craif just one month after meeting. Yasui’s innovative urinary biomarker method laid the foundation for the company’s technology. “Our goal is to make early cancer detection simple and routine, especially for those deterred by invasive tests or limited access to medical facilities,” Onose said.
In Japan, miSignal is already generating revenue through partnerships with over 1,000 medical institutions and 600 pharmacies, serving 20,000 users. Craif reported $5 million in revenue in 2024 and aims to reach $15 million by the end of 2025. The company offers single tests and subscription models, with many users opting for regular screenings. Craif plans to expand miSignal to detect 10 cancer types by year-end and explore applications for non-cancerous conditions like dementia.
The new funding will fuel Craif’s U.S. expansion, including clinical trials targeting FDA approval by 2029. The company operates an R&D lab in Irvine, California, and plans to open a business office in San Diego. Craif has begun collecting pancreatic cancer samples with 30 medical institutions across 15 U.S. states. “Our technology has the potential to transform cancer screening into a routine part of life,” said Onose.
Craif faces competition from companies like Grail and Freenome, which focus on cfDNA-based tests, but its urine-based miRNA approach sets it apart. With growing recognition of miRNA’s role in cancer biology—highlighted by its link to the 2024 Nobel Prize—Craif is poised to make early detection more accessible and effective, potentially saving lives through timely intervention.