For decades urine tests for cancer looked almost solely at bladder disease. Now the same everyday sample can flag early signs of many other cancers as well.
Craif has just raised US$33 million in a Series D round to drive its multi-cancer urine test into the United States. The financing, co-led by Granite-Integral and diagnostics maker Tauns Laboratories Inc (TYO: 197A), brings the Japanese firm’s total capital to roughly US$88 million.
Proceeds will scale research and development at its new San Diego lab, which opened in April, fund a prospective clinical study focused on pancreatic cancer, and prepare a reimbursement-driven U.S. launch. CEO Ryuichi Onose relocated to San Diego earlier this year to oversee the expansion personally, following the establishment of a U.S. subsidiary and partnerships with 30 medical institutions across 15 states.
Craif’s flagship test, miSignal, uses AI to analyse microRNA molecules in urine. These small molecules appear in higher concentrations when cancer cells are present. Patients collect a sample at home and send it for analysis.
In Japan, the test already screens for 10 common cancers, including pancreatic, lung, breast, stomach, colorectal, oesophageal and ovarian. It has been performed more than 110,000 times across more than 2,500 medical institutions and thousands of pharmacies. Peer-reviewed studies report accuracy of roughly 90 per cent across stages.
Founded in 2018 as a Nagoya University spin-out, Craif aims to build a broader urine-analysis platform for early disease detection, with cancer as the first step. Onose has spoken of starting the company after losing family members to late-diagnosed cancers, underscoring the personal drive behind the tech.
ANRIの投資先で、尿がんリスク検査「マイシグナル」を提供しているCraifが、総額約53億円のシリーズDラウンドを実施しました。
【どんな会社か】
Craifは、尿中に含まれるマイクロRNAを独自技術で捉え、AIで解析することで、がんのリスクを評価する技術を開発しているスタートアップです。… https://t.co/SaRb1iGjrM
— シードベンチャーキャピタルANRI (@ANRI_VC) August 20, 2026
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A growing North American field
Craif’s U.S. ambitions place it among a modern wave of North American companies pursuing urine-based multi-cancer screening beyond bladder disease.
TOBY leads with a test that reads volatile organic compounds in urine through mass spectrometry and AI. It recently gained FDA Breakthrough Device Designation and aims to detect more than 10 cancers.
Close behind, MiRNA Scientific offers the miR Sentinel test, which uses a urine sample to detect and classify prostate cancer risk without prostate-specific antigen (PSA) blood tests or biopsies. Another, PanGIA Biotech, applies machine learning to broader biomolecular patterns in urine, with strong early results in prostate cancer and plans to expand to several other types. BioMark Diagnostics Inc (OTCMKTS: BMKDF) (CNSX: BUX) (FRA: 2OB), meanwhile, focuses on metabolic markers such as polyamines and has secured U.S. patent protection for a urine-based lung-cancer screen that it intends to widen further.
These firms compete on accessibility and non-invasiveness yet differ in the biological signals they read, such as microRNA, volatile compounds, broader biochemical patterns or metabolites. Advances in AI and genetic sequencing have finally made it possible to find these tiny molecular signals, turning urine into a window on several cancers throughout the body.
Read more: Prestigious medtech intelligence firm recognizes Breath Diagnostics for innovation
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