microRNAs—molecules that regulate gene expression and play a critical role in cancer initiation and progression—were the focus of the 2024 Nobel Prize in Physiology or Medicine. Since its founding in 2018, Craif has been at the forefront of microRNA-based research, pioneering proprietary technologies for their precise detection in urine.
microRNAs—tiny molecules deeply involved in the onset and progression of cancer—have long been a focus of medical research. In 2024, their importance was globally recognized when they were featured in the Nobel Prize in Physiology or Medicine.
However, detecting microRNAs has historically been a major challenge. They exist in only trace amounts in body fluids and are extremely fragile, making them difficult to capture and analyze with precision.
The key to overcoming this challenge lies in exosomes—microscopic capsules secreted by cells. These exosomes act as protective carriers, shielding microRNAs from degradation and preserving them in a stable state.
Craif has developed a proprietary technology that efficiently isolates these exosomes from urine and precisely analyzes the microRNAs they contain. This innovation enables the accurate detection of microRNAs that were previously difficult to identify, delivering highly reliable and reproducible data to support early disease detection.
As of April 2025, this AI algorithm is capable of detecting 10 different types of cancer — including esophageal, gastric, pancreatic, lung, colorectal, ovarian, breast, kidney, bladder, and prostate cancers. Notably, for early-stage pancreatic cancer, the AI has demonstrated world-leading performance: a 93% sensitivity (correctly identifying cancer) and a 93% specificity (correctly ruling it out), as published in a peer-reviewed scientific journal.
Based on this large-scale data, we have developed AI-powered algorithms that analyze these patterns to predict an individual’s risk of cancer.
In collaboration with Hokkaido University Hospital and Iwanai Kyokai Hospital, Craif conducted a real-world study in Iwanai Town, Hokkaido, with the support of local residents.
In this study, 100 healthy residents underwent screening using miSignal Scan, leading to the successful detection—and subsequent treatment—of stage 0 (very early-stage) lung cancer in one participant.
Detecting cancer before symptoms appear has long been a major challenge in clinical practice. This achievement marks a significant milestone toward the real-world implementation of miSignal Scan. By working hand in hand with local communities and healthcare institutions, we are beginning to make early cancer detection not just a possibility, but a reality.
Craif is developing a novel medical device that supports the diagnosis of pancreatic cancer by combining urinary microRNA profiling with advanced AI (artificial intelligence) analysis.
This device calculates a risk score based on the expression levels and patterns of microRNAs found in urine, and classifies the result as either “positive” or “negative” to assess the likelihood of pancreatic cancer.
Similar to tumor marker tests and abdominal ultrasound, this diagnostic tool is intended for individuals with clinical symptoms or risk factors for pancreatic cancer. It serves as a decision-support tool to determine whether further detailed examination is warranted.
The device is currently undergoing a pivotal clinical trial in collaboration with multiple medical institutions across Japan to validate its reliability and performance. Craif aims to submit a regulatory application to Japan’s Ministry of Health, Labour and Welfare in 2026 and is actively preparing for manufacturing and commercialization.
This innovative technology aspires to become a new option for the early detection and accurate diagnosis of pancreatic cancer—conditions under which prompt intervention can significantly improve patient outcomes.
