Craif Raises $22M for Early Cancer Detection

The Global Impact of Cancer and Innovative Detection Methods

Cancer represents a leading cause of mortality on a global scale. Recent data from the National Cancer Institute indicates approximately 20 million new cancer diagnoses and 9.7 million cancer-related fatalities occurred worldwide in 2022. Projections suggest this number will increase to 29.9 million new cases by the year 2040.

Craif: Pioneering AI-Powered Early Cancer Detection

Founded in 2018 as a spin-off from Nagoya University in Japan, Craif is developing an AI-driven software solution for the early detection of cancer. The company leverages the potential of microRNA (miRNA) in its innovative approach.

Recently, Craif secured $22 million in Series C funding. This investment will facilitate expansion into the U.S. market and further strengthen its research and development efforts.

Funding Details and Company Valuation

Ryuichi Onose, co-founder and CEO of Craif, revealed in an interview with TechCrunch that the Series C funding round valued the company at just under $100 million.

X&KSK, a previous investor, spearheaded the latest funding initiative. Additional investors included Unreasonable Group, marking its first investment in a Japanese startup, alongside TAUNS Laboratories, Daiwa House Industry, and Aozora Bank Group. To date, Craif has raised a total of $57 million.

The Genesis of Craif: A Personal Mission

Craif’s origins are rooted in the personal experiences of its founder. Ryuichi Onose witnessed the impact of cancer firsthand through the diagnoses of both his grandparents.

This deeply personal connection fueled a strong desire to contribute to solutions for addressing the challenges posed by cancer. Onose, in collaboration with Takao Yasui, an associate professor at Nagoya University, co-founded Craif shortly after their initial meeting.

Yasui had previously developed a novel methodology for early cancer detection utilizing urinary biomarkers.

Addressing Challenges in Traditional Cancer Screening

Early detection of treatable conditions can prove difficult. Conventional diagnostic techniques, such as blood tests, can be invasive, potentially deterring individuals from undergoing regular screenings, as Onose explained.

Furthermore, limited access to healthcare facilities in certain regions presents obstacles to convenient cancer testing for many individuals.

Craif’s Solution: A Noninvasive Urine-Based Test

Craif is focused on overcoming these obstacles by offering a noninvasive, urine-based test designed for early cancer detection, even at Stage 1.

“The test can be conveniently administered at home and utilizes sophisticated microRNA analysis, enhancing the accessibility and effectiveness of early detection,” Onose stated. “Our target demographic consists of health-conscious individuals who prioritize cancer prevention but face challenges with traditional screening methods due to time constraints, cost, and accessibility issues.”

Competitive Landscape in Early Cancer Detection

The field of early cancer detection is witnessing growth, with several startups emerging, including Grail, Freenome, DELFI Diagnostics, and ClearNote Health.

Craif’s Differentiation: miRNA and Urine Analysis

Craif distinguishes itself from competitors by employing microRNA as a biomarker, rather than the more commonly used cfDNA (cell-free DNA). Additionally, the company utilizes urine samples for analysis.

Onose highlighted that miRNA, recognized with the 2024 Nobel Prize, plays a crucial role in cancer biology, even in its earliest phases. Unlike cfDNA, miRNA is actively secreted by nascent cancer cells, making it particularly well-suited for early detection.

The Advantages of Urine-Based Biomarker Analysis

The use of urine offers unique advantages. Onose explained that urine is easily obtained and noninvasive, providing significant scientific and practical benefits.

Urine samples contain fewer impurities compared to other biological samples, resulting in clearer biomarker signals. This reduces measurement errors, such as those caused by hemolysis in blood samples, and lowers testing costs.

miSignal: Craif’s Revenue-Generating Product

Craif’s initial product, miSignal, is a test that assesses the risk of seven different cancers – pancreatic, colorectal, lung, stomach, esophageal, breast, and ovarian – using urinary miRNA. The product is currently generating revenue in Japan.

Distribution channels include clinics, pharmacies, direct-to-consumer sales, and corporate wellness programs, providing diversified revenue streams.

Company Growth and Financial Performance

“We have established partnerships with over 1,000 medical institutions and approximately 600 pharmacies in Japan, serving around 20,000 users,” Onose shared with TechCrunch. “Our team comprises 73 dedicated professionals.”

The company offers both single tests and subscription packages for regular monitoring, with a significant proportion of users opting for subscription plans. Craif reported $5 million in revenue in 2024 and projects $15 million in revenue by the end of the current year.

Future Expansion and Research Directions

Craif plans to expand the scope of miSignal to encompass 10 different cancer types this year. Furthermore, the company is preparing to apply its technology to the early detection of non-cancerous conditions, such as neurodegenerative diseases like dementia.

Global Expansion and FDA Approval

Craif maintains a research and development laboratory in Irvine, California, and intends to establish a new office in San Diego to manage its business operations.

The recent funding will support the company’s entry into the U.S. market with its microRNA-based early cancer detection test. Craif aims to complete clinical trials in the U.S. around 2029 and subsequently file for FDA approval.

The company has already initiated the collection of pancreatic cancer samples in collaboration with 30 medical institutions across 15 U.S. states.

Note: This article was updated to provide clarification regarding Craif’s plans for clinical trials in the United States.