Craif Raises $22M to Expand AI-Powered Early Cancer Detection
Early cancer detection remains one of the most powerful tools in reducing cancer-related deaths, but traditional methods often fall short in accessibility and comfort. If you're searching for early cancer detection startup news, or wondering about AI-driven cancer detection advancements, Craif is leading a promising charge. Recently, this innovative company secured $22 million in Series C funding to further its mission of revolutionizing cancer screening with AI-powered microRNA (miRNA) analysis. Craif’s approach, using a non-invasive urine-based test, aims to make early-stage cancer detection more accurate, affordable, and accessible.
Cancer continues to be a global health crisis, accounting for nearly 20 million new cases and 9.7 million deaths in 2022, according to the National Cancer Institute. That number is projected to soar to 29.9 million by 2040, highlighting the urgent need for better diagnostic solutions. Founded in 2018 as a spin-off from Nagoya University in Japan, Craif is tackling this challenge head-on with its breakthrough miRNA technology designed to detect cancer even at Stage 1, without invasive procedures like blood draws.
Craif’s $22 million Series C round was led by X&KSK, with additional backing from U.S.-based Unreasonable Group (marking its first investment in a Japanese company), TAUNS Laboratories, Daiwa House Industry, and Aozora Bank Group. This round brings Craif’s total funding to $57 million, with its latest valuation just shy of $100 million. With these resources, Craif is accelerating its expansion into the highly competitive U.S. healthcare market, a move expected to significantly drive demand for advanced cancer diagnostics.
At the heart of Craif’s innovation is its proprietary use of microRNA biomarkers extracted from urine samples. Unlike traditional tests relying on cell-free DNA (cfDNA), Craif’s miRNA-based approach benefits from the biological signals secreted by cancer cells at extremely early stages. This distinction is critical, especially since miRNA's importance was amplified following its association with the 2024 Nobel Prize in Medicine. According to co-founder and CEO Ryuichi Onose, miRNA allows for earlier, clearer, and more reliable detection compared to cfDNA.
Moreover, using urine for cancer testing offers substantial practical and scientific advantages. It's non-invasive, widely accessible, and significantly reduces errors often seen in blood-based diagnostics. Urine also contains fewer impurities, leading to clearer biomarker signals and cutting down on overall testing costs — an important consideration for healthcare providers and insurers alike, which can improve profitability and lower premiums.
Craif’s flagship product, miSignal, is already a commercial success in Japan. The test screens for the risk of seven major cancers — pancreatic, colorectal, lung, stomach, esophagus, breast, and ovarian — and is distributed through over 1,000 medical institutions and 600 pharmacies, in addition to direct-to-consumer sales and corporate wellness programs. With around 20,000 users and a growing demand for cancer risk assessment services, Craif’s flexible revenue model offers both one-time tests and subscription plans for regular monitoring — a lucrative strategy that supports recurring revenue streams.
Financially, Craif posted $5 million in revenue in 2024 and is targeting a tripling of its earnings to $15 million by the end of 2025. These impressive numbers reflect the growing market appetite for preventive healthcare solutions, particularly as consumers become more proactive about their health in the wake of the COVID-19 pandemic.
Looking ahead, Craif plans to expand miSignal’s capabilities to detect ten types of cancers by the end of this year. Excitingly, the company is also adapting its platform for the early detection of non-cancerous diseases such as neurodegenerative disorders, including dementia — tapping into another high-demand and high-cost segment of healthcare.
As part of its global expansion, Craif has established a research and development facility in Irvine, California, and plans to open a business office in San Diego. These U.S. bases will support its goal of completing clinical trials by 2029 and eventually obtaining FDA approval for its miRNA-based early detection tests. Craif is already collaborating with 30 medical institutions across 15 U.S. states to collect pancreatic cancer samples, laying the groundwork for large-scale clinical validation.
By focusing on non-invasive cancer screening, AI-based diagnostic software, and affordable early detection methods, Craif is positioning itself at the forefront of a healthcare revolution. Its technology aligns perfectly with trends in personalized medicine, home healthcare services, and preventive diagnostics.
As Craif moves toward FDA approval and broader U.S. adoption, the startup's growth trajectory could reshape how healthcare systems worldwide approach cancer detection — making regular, non-invasive, and highly accurate screening a new standard of care.
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