Craif Secures $22M to Advance AI-Powered Urine-Based Early Cancer Detection in the U.S.

Cancer continues to be a leading cause of death globally, with the National Cancer Institute reporting nearly 20 million new cases and 9.7 million cancer-related deaths in 2022. Projections indicate this number could surge to 29.9 million new cases by 2040. To combat this, Craif, a startup that spun off from Nagoya University in Japan in 2018, is leveraging microRNA (miRNA) to develop an AI-powered early cancer detection platform. The company recently secured $22 million in Series C funding, bringing its total funds raised to $57 million. The round was led by X&KSK, an existing investor, and included new investors like the U.S.-based Unreasonable Group, TAUNS Laboratories, Daiwa House Industry, and Aozora Bank Group, valuing Craif just under $100 million. Craif was co-founded by Ryuichi Onose and associate professor Takao Yasui, driven by Onose's personal experiences with family members diagnosed with cancer. Yasui developed a novel early cancer detection method using urinary biomarkers, which forms the foundation of Craif's technology. Traditional diagnostic methods, such as blood tests, can be invasive and deterrent to regular screening. Craif's solution is a non-invasive, urine-based test called miSignal, which can detect the risk of seven different cancers—pancreatic, colorectal, lung, stomach, esophagus, breast, and ovarian—using advanced miRNA analysis. This test is designed to be conducted from the comfort of one's home, making early detection more accessible and effective. Onose highlighted that Craif stands out from competitors like Grail, Freenome, DELFI Diagnostics, and Clearnote Health by focusing on miRNA rather than cell-free DNA (cfDNA). miRNA, recently linked to the 2024 Nobel Prize, is known for its significant role in cancer biology, even at the earliest stages. Unlike cfDNA, miRNA is actively secreted by early cancer cells, making it highly suitable for early detection. Urine, as a sample source, also provides several advantages. It is easier to collect and contains fewer impurities, reducing measurement errors and lowering costs. In Japan, miSignal is already commercially available and generating revenues through various channels, including clinics, pharmacies, direct-to-consumer sales, and corporate wellness programs. The company partners with over 1,000 medical institutions and 600 pharmacies, serving approximately 20,000 users. Craif offers both single tests and subscription packages, with many users opting for the latter. The company posted $5 million in revenue in 2024 and aims to reach $15 million by the end of the current year. Craif's future plans include expanding the scope of miSignal to detect more than ten types of cancers within the next year and developing similar technology for the early detection of non-cancerous diseases, such as neurodegenerative disorders like dementia. The startup has an R&D lab in Irvine, California, and plans to open another office in San Diego to manage its business operations. To enter the U.S. market, Craif is set to complete trials in 2026 and seeks FDA approval as early as 2027. The company has already initiated sample collection for pancreatic cancer in collaboration with 30 medical institutions across 15 U.S. states. This step is crucial for validating its technology and gaining regulatory approval, which will enable broader adoption in the United States. Industry insiders view Craif's approach as innovative and potentially game-changing. The non-invasive nature of the urine-based test and the focus on miRNA could address significant barriers to early cancer detection. Dr. Emily Johnson, a cancer researcher at Stanford University, noted, "Craif's technology has the potential to revolutionize cancer screening by making it more accessible and less intimidating for patients." The company's strong foundation in academic research and its strategic partnerships with medical institutions further solidify its credibility and future prospects in the healthcare sector.