Craif Inc. Secures $300M to Power Global Expansion of Revolutionary miRNA-Based Cancer Diagnostics

Craif Inc., a trailblazer in molecular diagnostics, is thrilled to announce the successful raising of $300 million in its latest funding round. This milestone capital infusion underscores the strength of our innovative approach, which marries the power of miRNA analysis and machine learning with a clear mission to revolutionize early cancer detection. Since launching our proprietary platform in Japan in 2022, Craif has rapidly built confidence in its groundbreaking miSignal test, which currently screens for seven types of cancers—including pancreatic, ovarian, esophageal, lung, breast, colorectal, and gastric—and has achieved an impressive over 400% year-over-year revenue growth. The new funding will accelerate the further commercialization of the miSignal test while also bolstering our clinical trial efforts aimed at developing an in vitro diagnostic test specifically for pancreatic cancer among high-risk populations, such as those with diabetes or a history of pancreatitis. This particular test is on track to pursue FDA and PMDA approval, with plans for insurance reimbursement in the U.S. and inclusion in Japan’s National Healthcare System once approved, which is anticipated by the first half of 2027 following the clinical trial launch in April 2024. In tandem, Craif USA—established in 2023—will focus on expanding our presence in the United States, where the demand for innovative cancer diagnostics, especially for pancreatic cancer, remains critically high. The funds will support strategic clinical initiatives, bolster regulatory pathways, and further develop our US portfolio to address the unmet needs within the competitive landscape of cancer diagnostics. This remarkable achievement marks a pivotal beginning as we continue our journey to transform early cancer detection and improve patient outcomes globally.