Locations
Irvine, CA, USA · Tokyo, Japan · Tokyo, Japan
industry
Biotechnology
Size
11-50 employees
Stage
Series C+
founded in
2018
CRAIF is a molecular diagnostics company leveraging miRNA and machine learning for early cancer detection. Our proprietary platform, launched in Japan in 2022, powers the MiSignal test, which screens for seven cancers (pancreatic, ovarian, esophageal, lung, breast, colorectal, and gastric) and has seen over 400% YoY revenue growth. In parallel with the commercialization of MiSignal, we have started the clinical trial for the IVD test - pancreatic cancer diagnostic test for high-risk populations (e.g., diabetes, pancreatitis, etc.). This is a test seeking FDA/PMDA approval and planned to be reimbursed by insurance companies in the U.S. and reimbursed by the National Healthcare System in Japan. The clinical trial in Japan started in April 2024 and is planned to obtain approval in H1 2027. CRAIF USA was established in 2023 to bring this platform to the U.S. market, focusing on pancreatic cancer due to the high unmet need.
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