• Craif raised $22 million to expand its AI-powered, urine-based early cancer detection test into the U.S. and enhance R&D.
  • The company uses microRNA biomarkers and non-invasive urine samples, offering earlier and more accurate detection than many competitors.
  • Craif’s miSignal test is already generating revenue in Japan and aims to cover more cancer types and enter the U.S. market by 2029.

Craif, a Japanese biotech startup spun out from Nagoya University in 2018, has secured $22 million in Series C funding to accelerate its expansion into the United States and advance research on its pioneering early cancer detection platform.

The round, led by existing investor X&KSK and joined by Unreasonable Group (making its first Japanese investment), TAUNS Laboratories, Daiwa House Industry, and Aozora Bank Group, brings Craif’s total funding to $57 million and values the company just under $100 million.

Craif’s mission is personal for co-founder and CEO Ryuichi Onose, whose family’s cancer battles inspired him to launch the company with Nagoya University associate professor Takao Yasui.

Together, they developed a non-invasive, AI-powered test that uses microRNA (miRNA) biomarkers found in urine to detect cancer at very early stages-even as early as Stage 1.

Unlike traditional blood-based tests, which can be invasive and deter regular screening, Craif’s urine-based approach is designed for ease and accuracy, allowing users to collect samples at home.

The use of miRNA-recently recognized for its role in cancer biology by the 2024 Nobel Prize-offers clearer, more reliable signals than cell-free DNA (cfDNA), and urine’s low impurity levels further reduce errors and costs.

Craif’s flagship product, miSignal, already detects seven types of cancer and is distributed through over 1,000 clinics and 600 pharmacies in Japan, serving about 20,000 users.

The company reported $5 million in revenue for 2024 and targets $15 million by year-end, with many customers opting for subscription-based regular testing.

With the new funding, Craif plans to expand miSignal to cover ten cancer types, begin clinical trials in the U.S. (with FDA approval targeted by 2029), and explore applications for neurodegenerative diseases like dementia.

The company has established an R&D lab in Irvine, California, and will soon open a San Diego office to support its U.S. operations.

Edited by Annette George