Cancer remains one of the leading causes of death globally, with the National Cancer Institute noting nearly 20 million new cases and approximately 9.7 million deaths attributed to the disease in 2022. This figure is projected to escalate to nearly 30 million new cases by 2040.
In response to this pressing health crisis, Japanese startup Craif, which emerged from Nagoya University in 2018, is pioneering an innovative, AI-driven software for the early detection of cancer. Recently, the company secured $22 million in Series C funding, allowing it to further penetrate the U.S. market while enhancing its research and development efforts.
Ryuichi Onose, Craif’s co-founder and CEO, shared that the company completed its funding round with a valuation just shy of $100 million. The recent funding was led by X&KSK and included participation from investors like the U.S.-based Unreasonable Group and others. Craif has raised a total of $57 million to date.
Onose’s inspiration to tackle cancer is deeply personal, stemming from the diagnoses of his grandparents. This personal connection motivated him to create Craif alongside Takao Yasui, who had developed an early cancer detection method using urinary biomarkers.
Traditional cancer diagnostic methods can be invasive, leading many to shy away from routine screenings, especially where healthcare access is limited. In contrast, Craif’s innovative system offers a non-invasive urine test that facilitates early detection of various cancer types, even at Stage 1. This test can be done at home and utilises advanced microRNA analysis, making the process easier for health-conscious individuals who struggle with time, cost, and accessibility.
Current startups in this domain, such as Grail and Freenome, primarily rely on cell-free DNA (cfDNA) as biomarkers. However, Craif distinguishes itself by harnessing microRNA, which is actively released by early-stage cancer cells. Onose highlights the advantages of using urine for testing, noting its non-invasive nature and lower impurity levels which yield clearer biomarker signals, thereby reducing measurement errors.
Craif’s flagship product, miSignal, is designed to assess the risk of seven different cancers, including pancreatic and breast cancer. The company has already established a revenue stream in Japan, partnering with over 1,000 medical institutions and 600 pharmacies to serve approximately 20,000 users. Their revenue model incorporates both single tests and subscription options for ongoing testing, with earnings projected to reach $15 million by year-end 2024.
Looking ahead, Craif plans to broaden its capabilities by extending miSignal to detect more cancer types and exploring the early detection of non-cancerous ailments like dementia. The company operates an R&D laboratory in Irvine, California, and will be opening an additional office in San Diego for business operations.
The new funding will support Craif’s efforts to introduce miSignal to the U.S. market, with clinical trials planned for completion by the end of 2026 and potential FDA approval by 2027. The company is also actively collecting pancreatic cancer samples through partnerships with 30 medical institutions across 15 states in the U.S.
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