Cancer is one of the leading causes of death globally, with approximately 20 million new cases and 9.7 million cancer-related deaths reported worldwide in 2022, according to The National Cancer Institute. Projections indicate that this number will rise to 29.9 million new cases by 2040.

In response to this growing concern, Craif, a company spun off from Nagoya University in Japan in 2018, is developing an AI-powered early cancer detection software using microRNA (miRNA). The company has recently raised $22 million in Series C funding to further expand into the U.S. market and bolster its research and development efforts.

Ryuichi Onose, co-founder and CEO of Craif, revealed to TechCrunch that the company completed its Series C funding round with a valuation of nearly $100 million.

The funding round was led by existing investor X&KSK, with participation from new investors, including U.S.-based Unreasonable Group, TAUNS Laboratories, Daiwa House Industry, and Aozora Bank Group. This investment brings Craif’s total funding to $57 million to date.

Craif’s journey began when Onose’s family was affected by cancer, with both his grandparents being diagnosed with the disease. This personal experience sparked a strong commitment to addressing the cancer issue. Onose and Takao Yasui, an associate professor at Nagoya University, co-founded Craif shortly after meeting, with Yasui having developed a new method for early cancer detection using urinary biomarkers.

Traditional diagnostic methods, such as blood tests, can be invasive and may deter people from undergoing regular screenings, according to Onose. Furthermore, limited access to medical facilities in certain areas can make it challenging for individuals to access cancer testing.

To address these gaps, Craif aims to provide a non-invasive urine-based test that enables early cancer detection, even at a very early stage, such as Stage 1.

“Our 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 explained. “Our target 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.”

Several startups, including Grail, Freenome, DELFI Diagnostics, and Clearnote Health, are also working on early cancer detection platforms.

Craif differentiates itself by utilizing microRNA as a biomarker, rather than cfDNA (cell-free DNA), and using urine as the sample source.

“miRNA, which recently gained recognition after being linked to the 2024 Nobel Prize, plays a significant role in cancer biology, even at the earliest stages,” Onose said. “Unlike cfDNA, miRNA is proactively secreted by early cancer cells, making it particularly suitable for early cancer detection.”

Another unique aspect of Craif’s product is its use of urine, which Onose believes has several scientific and practical benefits. Urine samples have fewer impurities than other samples, making biomarker signals clearer and reducing measurement errors, such as those caused by hemolysis in blood. This also helps reduce testing costs.

Craif’s first product, miSignal, a test that detects the risk of seven different cancers (pancreatic, colorectal, lung, stomach, esophagus, breast, and ovarian) using urinary miRNA, is already generating revenue in Japan. The product is distributed through various channels, including clinics, pharmacies, direct-to-consumer sales, and corporate wellness programs.

“We have partnered with over 1,000 medical institutions and approximately 600 pharmacies in Japan, serving around 20,000 users. Our team consists of 73 dedicated employees,” Onose told TechCrunch.

The revenue model offers both single tests and subscription packages for regular testing, with many users opting for subscription plans. Craif posted $5 million in revenue in 2024 and aims to generate $15 million by the end of this year, according to Onose.

Craif plans to broaden the scope of miSignal to include more than ten different types of cancers in the coming year. Additionally, the startup is preparing to utilize its technology for the early detection of non-cancerous diseases, such as neurodegenerative disorders like dementia.

Craif has an R&D lab in Irvine, California, and plans to open another office in San Diego to handle its business operations.

The new funding will help the startup enter the U.S. market with its miSignal, aiming to complete trials in the U.S. by the end of 2026 and obtain FDA approval as early as 2027.

Craif has already begun collecting pancreatic cancer samples in collaboration with 30 medical institutions across 15 U.S. states.