Four years after launch, miSignal is in use in all 47 prefectures, and Craif holds joint research agreements with 50 hospitals, university hospitals, and cancer centers.

Craif Inc., a bio-AI company working on early cancer detection from urine, said today that its urine-based cancer risk test miSignal is now in use at more than 2,000 medical institutions in Japan. Craif says it will keep bringing new work on optimizing cancer care to as many people as possible, in pursuit of its stated mission, a society in which people live out their natural lifespan.

miSignal launched in February 2022. In the roughly four years since, it has been adopted in all 47 prefectures by general hospitals, health checkup facilities, and clinics, and it is increasingly built into comprehensive health checkups, mobile screening programs, and corporate health examinations.

The test extracts microRNA from a urine sample and analyzes it with AI. Craif separately holds joint research agreements with 50 medical institutions in Japan, including general hospitals, university hospitals, and cancer centers, for clinical research. Research on early pancreatic cancer detection using urinary microRNA was published in eClinicalMedicine, a journal in the Lancet family, on November 12, 2024.

A list of adopting institutions is available at https://misignal.jp/medical/. Only institutions that have given permission to be listed appear there.

Why medical institutions are adopting miSignal

Craif works with local governments and universities to improve early detection and early treatment in regions where geographic barriers keep screening rates low.

Institutions give four main reasons for adopting the test:

• ccess: a way to raise screening rates in areas where distance limits access to cancer screening.
• Reported clinical result: in one reported case, a Stage 0 lung cancer was found in a person screened with miSignal Scan.
• Peer-reviewed evidence: research on early pancreatic cancer detection using urinary microRNA, published in eClinicalMedicine, a journal in the Lancet family, on November 12, 2024.
• Ease of adoption: no specialized equipment and no dedicated staff, so the test fits into existing clinical workflows.

What adopting institutions say

Tokyo Medical Clinic: "The main strength, in our view, is that a single urine sample can point to where the cancer is. It can also pick up cancers such as pancreatic cancer that are hard to catch early with imaging alone."

e-Health Clinic Shinjuku: "We compared test kits from several companies. We chose miSignal because the evidence behind it is solid and because it reports results by cancer site."

Chunichi Hospital Health Checkup Center: "Three things decided it for us: how quickly we could put it to use, how simple it is, and the fact that results come back by cancer type. Knowing which sites are high risk makes our plan for follow-up testing clear, which is a real help on the hospital side."

Institutions considering miSignal can find details at https://misignal.jp/for-medical.

What miSignal Scan is

miSignal Scan extracts microRNA from urine and analyzes it with AI to assess risk for 10 types of cancer, including pancreatic cancer, reported by cancer type and from Stage 1. It requires only a urine sample, with no physical burden on the person tested. Ovarian and breast cancer are assessed for women only, prostate cancer for men only. Details are at https://misignal.jp/.

miSignal Scan is not a medical device. It determines risk by statistical calculation from the information it analyzes. It does not replace a medical diagnosis of whether a person has cancer, and a low-risk result does not mean that cancer is absent or that cancer will not develop later.

About Craif

Craif is a bio-AI startup founded in 2018 to detect cancer early. It combines NANO IP (NANO Intelligence Platform), its own analytical platform for detecting a range of biomarkers such as DNA and microRNA from urine and other body fluids, with AI, to develop tests aimed at very early detection, early treatment, and early return to normal life. Craif's stated vision is a society in which people live out their natural lifespan.

• Company: Craif Inc. (Craif Kabushiki Kaisha; the company gives Craif Inc. as its own English name)
• Representative Director and CEO: Ryuichi Onose
• Founded: May 2018
• Business: research and development of next-generation tests for early detection of disease and personalized medicine, primarily in oncology, and provision of the miSignal urine-based cancer risk test
• Headquarters: 8-30 Shinogawamachi, Shinjuku, Tokyo, THE PORTAL iidabashi B1F

Web: https://craif.com/