## Japanese Startup Craif Secures $22M to Revolutionize Early Cancer Detection with Urine-Based AI
Cancer remains a global health crisis, with the National Cancer Institute reporting nearly 20 million new cases and 9.7 million deaths in 2022 alone. Projections indicate a significant rise, reaching nearly 30 million new cases by 2040. Addressing this urgent need, Craif, a Japanese startup specializing in non-invasive early cancer detection, has announced a $22 million Series C funding round. This investment will fuel the company’s expansion into the U.S. market and support further research and development of its innovative platform.
Craif, a spin-off from Nagoya University founded in 2018, is leveraging the power of microRNA (miRNA) and artificial intelligence to develop a groundbreaking early cancer detection software. The Series C funding, led by existing investor X&KSK, values the company at just under $100 million, bringing Craif’s total funding to $57 million. The round also saw participation from U.S.-based Unreasonable Group (marking their first investment in a Japanese startup), TAUNS Laboratories, Daiwa House Industry, and Aozora Bank Group.
The motivation behind Craif stems from a deeply personal experience. Co-founder and CEO Ryuichi Onose witnessed the devastating impact of cancer firsthand, with both his grandparents diagnosed with the disease. This inspired him to co-found Craif with Takao Yasui, an associate professor at Nagoya University, just a month after they met. Yasui had developed a novel method for early cancer detection using urinary biomarkers.
Traditional cancer diagnostic methods, such as blood tests, can be invasive, deterring some individuals from regular screening. Furthermore, access to medical facilities can be limited in certain areas, posing a challenge for convenient cancer testing. Craif aims to overcome these obstacles by offering a non-invasive, urine-based test capable of detecting cancer at its earliest stages, including Stage 1.
“The test can be conducted from the comfort of a patient’s home and is powered by advanced microRNA analysis, making early detection more accessible and effective,” explains Onose. “Our users are health-conscious individuals who are concerned about cancer but find it challenging to commit to conventional screenings due to time, cost, and accessibility constraints.”
Craif distinguishes itself from competitors like Grail, Freenome, DELFI Diagnostics, and Clearnote Health by utilizing microRNA as a biomarker instead of cell-free DNA (cfDNA) and by focusing on urine as the sample source.
“miRNA, which gained heightened recognition after being linked to the 2024 Nobel Prize, is known for its deep involvement in cancer biology even at the earliest stages,” Onose explained. “Unlike cfDNA, miRNA is proactively secreted by early cancer cells, making it particularly suitable for early cancer detection.”
The use of urine provides numerous advantages, including ease of collection, non-invasiveness, and fewer impurities compared to other samples, leading to clearer biomarker signals and reduced measurement errors.
Craif’s flagship product, miSignal, is already generating revenue in Japan. This test detects the risk of seven different cancers – pancreatic, colorectal, lung, stomach, esophagus, breast, and ovarian – using urinary miRNA. Distribution channels include clinics, pharmacies, direct-to-consumer sales, and corporate wellness programs.
The company currently partners with over 1000 medical institutions and approximately 600 pharmacies in Japan, serving around 20,000 users. With a team of 73 employees, Craif reported $5 million in revenue in 2024 and projects $15 million by the end of this year. The revenue model includes both single tests and subscription packages, with a strong uptake of the latter.
Looking ahead, Craif plans to expand miSignal’s scope to include ten different cancer types this year. The startup is also exploring the use of its technology for the early detection of non-cancerous diseases, such as neurodegenerative disorders like dementia.
With an existing R&D lab in Irvine, California, Craif intends to open another office in San Diego to manage its business operations. The new funding will play a crucial role in the company’s U.S. market entry, with plans to complete trials around 2029 and subsequently seek FDA approval. Craif has already initiated collaboration with 30 medical institutions across 15 U.S. states to collect pancreatic cancer samples, underscoring its commitment to revolutionizing early cancer detection on a global scale.