Japanese biotechnology startup Craif has secured $22 million in its latest Series C funding round to accelerate the development and international expansion of its groundbreaking early cancer detection technology.
Founded in 2018 as a spin-off from Nagoya University, Craif is developing a non-invasive diagnostic platform that utilises microRNA (miRNA) biomarkers found in urine to identify cancer at its earliest and most treatable stages.
Cancer remains a significant global health challenge, with the National Cancer Institute reporting nearly 20 million new cases and close to 10 million deaths worldwide in 2022. These figures are projected to rise to almost 30 million new cases by 2040, emphasising the urgent need for more effective early detection methods.
Craif’s innovative approach focuses on analysing miRNA molecules-small RNA fragments actively secreted by cancer cells during the initial phases of tumour development. This method differs from the more commonly used cell-free DNA (cfDNA) liquid biopsies, which typically detect cancer at later stages.
“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,” explained Ryuichi Onose, Craif’s co-founder and CEO. “Unlike cfDNA, miRNA is proactively secreted by early cancer cells, making it particularly suitable for early cancer detection.”
Using urine as the testing medium offers a painless, convenient alternative to blood draws, with fewer impurities that can interfere with biomarker detection, thus reducing errors and costs.
Craif’s flagship product, miSignal, is currently available in Japan and screens for seven types of cancer: pancreatic, colorectal, lung, stomach, oesophageal, breast, and ovarian. The test is distributed through a network of over 1,000 medical institutions and approximately 600 pharmacies, reaching around 20,000 users. Customers can choose between single tests or subscription plans, with many opting for ongoing monitoring. In 2024, the company generated $5 million in revenue and aims to triple that figure by the end of 2025.
The company’s origins are deeply personal for Onose, who was inspired by his grandparents’ battles with cancer. He partnered with Takao Yasui, an associate professor at Nagoya University who developed a novel urinary biomarker detection method, to launch Craif shortly after their initial meeting. Their objective was to overcome the limitations of conventional cancer screening, which often involves invasive procedures and is hindered by accessibility issues, especially in remote areas.
With the recent capital injection led by existing investor X&KSK and supported by new backers including the U.S.-based Unreasonable Group—marking its first investment in a Japanese startup—as well as TAUNS Laboratories, Daiwa House Industry, and Aozora Bank Group, Craif is poised for aggressive expansion into the U.S. market.
The company has established a research and development centre in Irvine, California, and plans to open a business office in San Diego to support clinical trials and regulatory efforts. It has already begun collecting pancreatic cancer samples in collaboration with 30 medical institutions across 15 U.S. states, aiming to complete trials by around 2029 and pursue FDA approval thereafter.
Beyond cancer, Craif is exploring applications of its miRNA platform for early detection of non-cancerous diseases such as neurodegenerative disorders, including dementia. This diversification could widen the impact of their technology within healthcare.
Furthermore, Craif’s selection for the prestigious Medtech Innovator 2024 accelerator further validates its potential. The programme offers medical technology startups mentorship and industry connections, assisting them in navigating regulatory pathways and scaling their innovations globally.