A urine-based cancer screening test developed by Japanese startup Craif Inc. has demonstrated its ability to detect early-stage cancer in a real-world pilot study, successfully identifying Stage 0 lung cancer in a woman who had not undergone screening in over five years.
The Nagoya University spin-off company distributed 100 free "miSignal" test kits to residents across Hokkaido towns between March 2024 and March 2025, with results presented at the Japanese Association for Chest Surgery's annual meeting in May 2025.
Non-Invasive Detection Technology
The miSignal test kit represents a significant advancement in cancer screening accessibility, requiring only a small urine sample to assess risk for up to seven cancer types simultaneously. The technology works by detecting microRNA, a biomarker closely associated with early-stage cancer development, to screen for malignancies in organs including the lungs, colon, and pancreas.
"We were able to detect and treat cancer that was difficult to find by X-ray," said Professor Tatsuya Kato of Hokkaido University Hospital, emphasizing the technology's particular value in rural or under-resourced regions like Hokkaido where medical resources are sparse.
Clinical Outcomes from Pilot Study
Among participants aged 60 or older who had not undergone lung cancer screening for five years or more, the test flagged a lung tumor in one woman in her 60s. Subsequent detailed medical examination confirmed the diagnosis as Stage 0 adenocarcinoma in situ—a non-invasive cancer that might otherwise have gone undetected through conventional screening methods. The patient underwent successful surgical treatment.
Beyond the lung cancer detection, Craif reported that precancerous conditions in the colon and pancreas were identified in six other participants during the survey, demonstrating the test's multi-organ screening capabilities.
Addressing Japan's Cancer Burden
The pilot study results come against the backdrop of Japan's significant cancer burden, where one in two people is expected to develop cancer in their lifetime. According to National Cancer Centre Japan statistics, one in four men and one in six women will ultimately die from the disease.
Craif Inc., established in 2018 as a spin-off from Nagoya University, designed the test kit specifically to be accessible in areas with limited healthcare infrastructure, eliminating the need for blood draws and complex medical procedures that can be barriers to regular screening in underserved communities.
