Cancer is one of the leading causes of death globally. The National Cancer Institute reported nearly 20 million new cancer cases and 9.7 million cancer-related deaths worldwide in 2022. Projections indicate an increase to 29.9 million new cases by 2040.
Craif, a company spun off from Nagoya University in Japan in 2018, utilizes microRNA (miRNA) to develop AI-powered early cancer detection software. The company recently raised $22 million in Series C funding to expand into the U.S. market and enhance its research and development.
Ryuichi Onose, co-founder and CEO of Craif, mentioned that their Series C funding round concluded with a valuation just under $100 million. The funding was led by X&KSK, an existing investor, along with the U.S.-based Unreasonable Group, marking its first investment in a Japanese startup. Other investors include TAUNS Laboratories, Daiwa House Industry, and Aozora Bank Group. Craif has raised a total of $57 million to date.
Craif was co-founded by Ryuichi Onose and Takao Yasui, inspired by Onose’s personal experiences with cancer in his family. Yasui, an associate professor at Nagoya University, developed a method for early cancer detection using urinary biomarkers.
Traditional diagnostic methods for treatable conditions, such as blood tests, can be invasive and deter regular screening. Additionally, access to medical facilities is limited in some areas, creating challenges for individuals seeking cancer testing. Craif aims to address these challenges by offering a non-invasive urine-based test for early cancer detection, even at very early stages like Stage 1.
The test, powered by advanced microRNA analysis, can be conducted at home, making early detection more accessible and efficient. Craif targets health-conscious individuals who face time, cost, and accessibility constraints with conventional screenings.
Several other startups, such as Grail, Freenome, DELFI Diagnostics, and Clearnote Health, are also developing platforms for early cancer detection. Craif distinguishes itself by utilizing microRNA as a biomarker and employing urine in its testing, unlike competitors who primarily use cell-free DNA.
MicroRNA, which gained attention after being associated with the 2024 Nobel Prize, plays a critical role in cancer biology from early stages. Unlike cfDNA, miRNA is actively secreted by early cancer cells, making it particularly suitable for early detection.
The use of urine is another distinguishing factor. Urine samples are easy to collect and non-invasive, providing clearer biomarker signals with fewer impurities compared to other samples. This reduces measurement errors and lowers testing costs.
Craif’s first product, miSignal, is already generating revenue in Japan by detecting the risk of seven different cancers using urinary miRNA. The product is distributed through clinics, pharmacies, direct-to-consumer sales, and corporate wellness programs, creating multiple revenue streams. The company partners with over 1,000 medical institutions and approximately 600 pharmacies in Japan, serving around 20,000 users with a dedicated team of 73 employees.
Craif’s revenue model includes both single tests and subscription packages for regular testing, with many users opting for subscriptions. The company reported $5 million in revenue in 2024 and aims for $15 million by year-end. Craif also plans to expand miSignal to include more than ten types of cancers next year and is preparing to apply its technology to early detection of non-cancerous diseases, such as neurodegenerative disorders like dementia.
With an R&D lab in Irvine, California, Craif intends to open another office in San Diego for business operations. The recent funding will assist in entering the U.S. market, with plans to complete trials by the end of 2026 and seek FDA approval by 2027.
The company has already begun collecting pancreatic cancer samples in collaboration with 30 medical institutions across 15 U.S. states.
