Craif, a startup spun out of Nagoya University in Japan in 2018, is developing an AI-driven early cancer detection platform using microRNA (miRNA) technology. The company has raised $22 million in a Series C funding round to fuel its expansion into the U.S. market and enhance its research and development capabilities.
In an interview, Craif co-founder and CEO Ryuichi Onose revealed that the round closed with the company valued at just under $100 million.
Cancer remains one of the top causes of death globally. The National Cancer Institute reported nearly 20 million new cases and 9.7 million cancer-related deaths in 2022, with projections estimating that figure will rise to 29.9 million new cases by 2040.
X&KSK, an existing investor, led Craif’s latest funding round, which brings the startup’s total capital raised to $57 million. Other participants included U.S.-based Unreasonable Group—making its first investment in a Japanese startup—along with TAUNS Laboratories, Daiwa House Industry, and Aozora Bank Group.
Craif’s mission is deeply personal for co-founder and CEO Ryuichi Onose, whose motivation stems from seeing both his grandparents diagnosed with cancer. These experiences sparked a determination to tackle the disease. Just a month after meeting, Onose and Takao Yasui, an associate professor at Nagoya University, co-founded Craif. Yasui had developed a novel method for early cancer detection using urinary biomarkers, which now underpins the company’s technology.
Early detection of treatable conditions remains a challenge, as traditional diagnostic tools like blood tests can be invasive—discouraging some individuals from undergoing regular screenings, Onose explained. He also noted that in many regions, limited access to healthcare facilities further complicates timely cancer testing.
Craif seeks to close these gaps with its non-invasive, urine-based testing solution, designed to detect cancer at very early 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,” Onose said. “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 sets itself apart by leveraging microRNA as a biomarker, rather than the more commonly used cell-free DNA (cfDNA) adopted by many competitors. Additionally, the company’s approach focuses on urine-based testing, offering a non-invasive alternative to traditional methods.
“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.”
Another distinctive feature of Craif’s product is its use of urine as a sample. Onose highlighted that urine is easy to collect and non-invasive, offering significant scientific and practical advantages. It contains fewer impurities compared to other sample types, resulting in clearer biomarker signals, which helps reduce measurement errors, such as those caused by hemolysis in blood samples, while also lowering the cost of testing.
Craif’s first product, miSignal, detects the risk of seven types of cancer (pancreatic, colorectal, lung, stomach, esophageal, breast, and ovarian) by analyzing urinary miRNA. The test is already generating revenue in Japan and is distributed through a variety of channels, including clinics, pharmacies, direct-to-consumer sales, and corporate wellness programs, providing multiple revenue streams with potential for future expansion, as stated by the CEO.
“We are partnered with over 1000 medical institutions and about 600 pharmacies in Japan, serving about 20,000 users. Our team consists of 73 dedicated employees,” Onose said.
Craif plans to expand miSignal to detect ten different types of cancer this year. The startup is also preparing to leverage its technology for the early detection of non-cancerous diseases, including neurodegenerative disorders such as dementia.
With an R&D lab in Irvine, California, Craif is set to open another office in San Diego to manage its business operations.
The new funding will support Craif’s entry into the U.S. market with its microRNA-based early cancer detection test, with trials scheduled to be completed around 2029 and plans to file for FDA approval.
Craif has already begun collecting pancreatic cancer samples in partnership with 30 medical institutions across 15 U.S. states.
