Craif is currently conducting a multicenter clinical study to validate a new medical technology that analyzes microRNAs in urine using AI to support the diagnosis of pancreatic cancer.
This trial represents a critical step toward obtaining regulatory approval from Japan's Ministry of Health, Labour and Welfare (MHLW) and bringing this technology into clinical use as software as a medical device (SaMD).

The study is being conducted with the participation of patients with pancreatic cancer, individuals at high risk of developing pancreatic cancer, and healthy individuals. By analyzing urine-derived microRNA profiles along with standard clinical data, the study aims to evaluate how accurately Craif's AI can detect pancreatic cancer.

Through this research, Craif is working to establish a novel diagnostic tool that can identify pancreatic cancer earlier and more accurately.

In collaboration with Hokkaido University Hospital and Iwanai Kyokai Hospital, Craif conducted a lung cancer screening study using miSignal Scan, involving 100 residents of Iwanai and Yoichi towns in Hokkaido

This prospective observational study was designed to evaluate the diagnostic performance of urine-based microRNA analysis for lung cancer, while also cancer incidence and participants' prognosis over time.

In this clinical study, miSignal Scan identified lung cancer risk in one of the participating residents, leading to the successful removal of stage 0 lung cancer (carcinoma in situ).

This initiative represents an important step toward validating the role of next-generation cancer screening in community health. Craif will continue expanding its efforts to assess how this technology can be implemented as a novel and accessible option for cancer screening nationwide.

Craif, in collaboration with Nagoya University and Fujita Health University, is conducting a pilot implementation study involving 100 residents in the Tokai region of Japan. The study evaluates the feasibility of miSignal Scan, a novel urine-based screening test designed to assess pancreatic cancer risk.

This study utilizes Craif’s proprietary technology that analyzes microRNAs in urine samples using AI-based algorithms, aiming to determine how early and accurately pancreatic cancer signals can be detected. In addition to assessing diagnostic performance, participants are being followed longitudinally to investigate how test results correlate with cancer incidence and overall health outcomes.

Pancreatic cancer is notoriously difficult to detect early due to its lack of specific symptoms in the initial stages, and no effective mass screening method has been established to date. This initiative represents a critical first step toward the social implementation of a world-first, non-invasive screening approach that uses only urine to identify early cancer signals—and is being conducted in conjunction with public awareness campaigns to address this pressing unmet need.