Startup Craif, dedicated to early cancer detection, raises $22 million in funding.
Cancer stands as one of the leading causes of death worldwide. It was reported that there were nearly 20 million new cases of cancer and 9.7 million deaths due to this disease.
Cancer has become one of the leading causes of death worldwide. According to the National Cancer Institute, nearly 20 million new cancer cases and 9.7 million cancer-related deaths were recorded globally in 2022. It is estimated that by 2040, the number of new cases will increase to 29.9 million.
Craif, a company that emerged from Nagoya University in Japan in 2018, is developing an artificial intelligence-driven early cancer detection software using microRNA (miRNA). Recently, the company raised $22 million in a Series C funding round, which will enable it to strengthen its presence in the U.S. market and expand its research and development efforts. Ryuichi Onose, co-founder and CEO of Craif, explained in an interview that the Series C funding round was completed with a valuation of nearly $100 million. Existing investor X&KSK led this round, increasing the total amount raised to date to $57 million, along with U.S. investor Unreasonable Group, a first investment in a Japanese startup, as well as TAUNS Laboratories, Daiwa House Industry, and Aozora Bank Group.
Craif's journey began when Onose experienced the impact of cancer on his family, as both of his grandparents were diagnosed with the disease. These personal experiences have motivated his commitment to the fight against cancer. Together with Takao Yasui, an associate professor at Nagoya University, he co-founded Craif a month after they met. Yasui had developed an innovative method for early cancer detection using urinary biomarkers. Onose mentioned that early detection of treatable conditions can be complicated, as traditional diagnostic methods like blood tests may be invasive, and many people avoid undergoing regular tests. Additionally, lack of access to medical facilities in some areas makes it difficult for individuals to easily obtain cancer screenings. Craif aims to fill these gaps by offering a non-invasive urine-based test that allows early cancer detection, even at very early stages, such as stage 1.
"The test can be performed from the comfort of the patient's home and is based on advanced microRNA analysis, making early detection more accessible and effective," explained Onose. "Our clientele consists of health-concerned individuals who fear cancer but find it challenging to attend conventional tests due to time, cost, and accessibility constraints." There are several startups in the sector creating platforms for early cancer detection, such as Grail, Freenome, DELFI Diagnostics, and Clearnote Health. Craif differentiates itself by using microRNA as a biomarker instead of cfDNA (circulating free DNA) like most of its competitors and by using urine.
"miRNA, which gained relevance after being linked to the 2024 Nobel Prize, is known for its profound involvement in cancer biology even at the earliest stages," stated Onose. "Unlike cfDNA, miRNA is actively secreted by early cancer cells, making it particularly suitable for early detection." Another distinctive aspect of their product is that it uses urine, which is easy and non-invasive and provides multiple scientific and practical benefits. Onose emphasized that urine has fewer impurities than other samples, making biomarker signals clearer, thus reducing potential measurement errors.
Craif's first product, called miSignal, is a test that detects the risk of seven different types of cancer (pancreatic, colorectal, lung, stomach, esophageal, breast, and ovarian) using urinary miRNA and is already generating revenue in Japan. These products are distributed through clinics, pharmacies, direct-to-consumer sales, and corporate wellness programs, offering various revenue sources that can expand. Craif has partnerships with over 1,000 medical institutions and around 600 pharmacies in Japan, serving about 20,000 users, and has a team of 73 employees.
The revenue model offers both individual tests and subscription packages for regular testing, with many users opting for subscription plans. The company reported revenue of $5 million in 2024 and aims to reach $15 million by the end of the year. Additionally, Craif plans to extend the capability of miSignal to include ten different types of cancer this year and is also preparing to use its technology for the early detection of non-cancerous diseases, such as neurodegenerative disorders.
The company has a research and development laboratory in Irvine, California, and plans to open another office in San Diego to handle its commercial operations. The new funds will help the startup enter the U.S. market with its microRNA-based early cancer detection test, aiming to complete trials in the U.S. by 2029 and submit a request for FDA approval. It has already begun collecting pancreatic cancer samples in collaboration with 30 medical institutions in 15 U.S. states.