Craif Advances AI-Powered Urine Test for Early Cancer Detection with $22M Funding

Cancer remains one of the leading causes of death worldwide, with nearly 20 million new cases and 9.7 million deaths reported globally in 2022. Projections estimate new cancer cases will rise to 29.9 million by 2040, underscoring the urgent need for improved early detection methods.

Founded in 2018 as a spin-off from Nagoya University, Craif is pioneering an AI-powered early cancer detection platform leveraging microRNA (miRNA) biomarkers found in urine. The company recently secured $22 million in Series C funding, boosting its valuation to nearly $100 million and enabling expansion into the U.S. market alongside enhanced research and development efforts.

Craif’s co-founder and CEO, Ryuichi Onose, was personally motivated by his family’s experience with cancer to develop accessible, non-invasive testing solutions. Traditional cancer screenings can be invasive, costly, and inaccessible for many, leading to missed opportunities for early intervention. Craif addresses these challenges with a urine-based test that patients can perform at home, powered by advanced AI analysis of urinary miRNA.

Unlike many competitors that utilize cell-free DNA (cfDNA), Craif’s technology focuses on miRNA, which is actively secreted by early-stage cancer cells and closely linked to cancer biology. This biomarker, combined with the clarity and ease of urine samples, enhances detection accuracy while reducing costs and patient discomfort.

Craif’s flagship product, miSignal, detects risk for seven cancers including pancreatic, colorectal, lung, stomach, esophagus, breast, and ovarian cancers. It is distributed through clinics, pharmacies, direct-to-consumer channels, and corporate wellness programs in Japan, serving approximately 20,000 users with over 1,000 medical institutions and 600 pharmacies partnered.

The company’s revenue model includes single tests and subscription packages, with many users opting for regular testing plans. In 2024, Craif posted $5 million in revenue and aims to triple that by year-end. Plans are underway to expand miSignal’s cancer detection capabilities to over ten cancer types and to adapt the technology for early detection of non-cancerous diseases such as neurodegenerative disorders.

With R&D facilities in Irvine, California, and plans to open a San Diego office, Craif is actively preparing for U.S. market entry. The company is conducting clinical trials in collaboration with 30 medical institutions across 15 states, targeting FDA approval for miSignal by 2027.

Implications and Future Directions

Craif’s innovative approach highlights the transformative potential of AI-powered biomarker analysis in making early cancer detection more accessible, non-invasive, and accurate. By leveraging urinary miRNA, the company addresses key barriers in traditional screening methods, potentially improving patient outcomes through earlier diagnosis and treatment.

As Craif expands its cancer detection portfolio and explores applications in neurodegenerative diseases, it exemplifies the growing convergence of AI, biotechnology, and personalized medicine. This trajectory opens new opportunities for healthcare providers, researchers, and patients worldwide, emphasizing the critical role of innovative diagnostics in global health.