Cancer is one of the biggest causes of death worldwide. The National Cancer Institute reported nearly 20 million new cancer cases and 9.7 million cancer-related deaths worldwide in 2022, with forecasts showing that new cases will grow to 29.9 million new cases by 2040.

Developed from Nagoya University in Japan in 2018, Craif is developing AI-powered early-stage cancer detection software using MicroRNA (MiRNA) and has raised $22 million in Series C funding to further expand to the U.S. market and strengthen its R&D.

Craif's co-founder and CEO Ryuichi Onose told TechCrunch in an interview with TechCrunch that the company completed a Series C financing with a valuation of less than $100 million.

Incumbent investor X&KSK leads the latest funding, which has raised a total of $57 million to date, as well as an unreasonable group of investors based in the U.S., its first investment in Japanese startup Tauns Laboratories, the Daiwa House industry and the Aozora Bank Group.

Craif's journey began with Onose seeing the effects of cancer on his family, both of his grandparents being diagnosed with the disease. These personal experiences have inspired a strong commitment to solving cancer problems. Onose and Takao Yasui, associate professors at Nagoya University, co-founded Craif one month after they met. Yasui has created a new method for early cancer detection using urinary biomarkers.

Onose said early detection of treatable conditions can be challenging because traditional diagnostic methods, such as blood tests, can be invasive, causing some people to avoid regular screenings. Additionally, according to Onose, the opportunity to access medical facilities in some areas is limited, so people can easily get cancer tests.

Craif's purpose is to address these gaps by providing non-invasive urine tests that can enable early cancer detection (such as Phase 1).

"The test can be performed from the comfort of the patient's home and is powered by advanced MicroRNA analysis, making early detection more accessible and effective," Onose said. "Our users are people who are health-conscious about cancer care, but have the challenge of routine screening due to time, cost and accessibility limitations."

Several startups are creating platforms for early cancer detection in the industry, such as Grail, Freenome, Delfi Diagnostics and Clearntote Health.

Craif, like most competitors, differentiates itself by using microRNA as a biomarker rather than CFDNA (cell-free DNA) and utilizes urine.

"Mirangelists associated with the 2024 Nobel Prize were known for their deep involvement in cancer biology at the earliest stages," Onose explained. "Unlike CFDNA, miRNAs are actively secreted by early cancer cells, making them particularly suitable for early cancer detection."

Another unique aspect of its product is the use of urine. Onose says urine is easy and non-invasive, providing many scientific and practical benefits. He added that it has fewer impurities than other samples, making the biomarker signal clearer. This helps reduce any measurement errors, such as hemolysis in the blood and funding in the test.

Craif's first product, the wrong test, which examines the risks of seven different cancers (pancreas, colorectal cancer, lung, stomach, esophageal breast, ovary) using urinary miRNAs, has generated revenue in Japan. The company's CEO said the products are distributed through clinics, pharmacies, direct-to-consumer sales and company health plans, providing a variety of revenue streams that can be expanded.

"We work with more than 1,000 medical facilities and about 600 pharmacies to serve about 20,000 users. Our team consists of 73 full-time staff," Onose told TechCrunch.

The revenue model provides a single test and subscription package for regular testing, and many users choose to subscribe to the plan. Onose told TechCrunch that it will earn $5 million in 2024 with the goal of generating $15 million by the end of the year.

Craig intends to expand the range of false signals to include more than a dozen different types of cancer in the coming year. Additionally, the startup is preparing to use its technology to detect noncancerous diseases early on, such as neurodegenerative diseases such as dementia.

Craif has opened a R&D lab in Irvine, California, and plans to open another office in San Diego to handle its business operations.

The new funding will help startups enter the U.S. market with its misleading intentions to complete the trial in the U.S. by the end of 2026 and obtain FDA approval by 2027.

It has begun collaborating with 30 medical institutions in 15 states in the United States to collect pancreatic cancer samples.