Craif Secures $22M to Expand AI Cancer Detection to US

Craif Raises $22 Million for US Expansion of AI-Powered Cancer Detection

Cancer remains a leading cause of death globally. The National Cancer Institute reported a significant number of cancer cases and deaths in 2022, with projections indicating a continued rise. Craif, a Japanese startup spun off from Nagoya University, aims to combat this trend with its innovative early cancer detection technology.

Craif has secured $22 million in Series C funding, bringing its total raised to $57 million. The round was led by existing investor X&KSK, with participation from Unreasonable Group, TAUNS Laboratories, Daiwa House Industry, and Aozora Bank Group. This funding will fuel Craif's expansion into the US market and further its research and development efforts.

Non-Invasive Early Cancer Detection

Craif's technology uses microRNA (miRNA) analysis in urine samples to detect cancer at early stages, even as early as Stage 1. This non-invasive approach addresses challenges associated with traditional methods like blood tests, which can be invasive and deter some individuals from regular screenings. The urine test offers greater accessibility and convenience, particularly for those with limited access to medical facilities.

The 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.

This method differentiates Craif from competitors like Grail, Freenome, DELFI Diagnostics, and Clearnote Health, which primarily utilize cell-free DNA (cfDNA) analysis. The use of miRNA, recognized for its role in cancer biology even at the earliest stages, and urine samples makes Craif's approach unique.

miRNA: A Key Biomarker for Early Detection

miRNA gained significant attention after its connection to the 2024 Nobel Prize. Unlike cfDNA, miRNA is actively secreted by early cancer cells, making it an ideal biomarker for early detection. Urine, being less prone to impurities than other samples, provides clearer biomarker signals and reduces measurement errors.

miSignal: Generating Revenue and Expanding Capabilities

Craif's flagship product, miSignal, detects the risk of seven different cancers (pancreatic, colorectal, lung, stomach, esophageal, breast, and ovarian) using urinary miRNA. Already generating revenue in Japan, miSignal is distributed through clinics, pharmacies, direct-to-consumer sales, and corporate wellness programs.

With over 1,000 partner medical institutions and 600 pharmacies in Japan, Craif serves approximately 20,000 users. The company offers both single tests and subscription packages, with many users opting for subscriptions. Craif reported $5 million in revenue in 2024 and aims to reach $15 million by the end of this year.

Future Plans: Expanding Cancer Types and Addressing Other Diseases

Craif plans to expand miSignal to detect more than ten cancer types in the coming year. The company is also exploring the use of its technology for early detection of non-cancerous diseases, such as neurodegenerative disorders like dementia.

US Market Entry and FDA Approval

With its R&D lab in Irvine, California, and plans for a new office in San Diego, Craif is preparing for its US market entry. The company aims to complete US trials for miSignal by the end of 2026 and secure FDA approval as early as 2027. It has already begun collecting pancreatic cancer samples in collaboration with 30 medical institutions across 15 US states.