A urine-based approach to cancer detection is moving into expanded US clinical development, with a prospective study planned to evaluate pancreatic cancer detection using artificial intelligence to analyze microRNA in urine.
The technology, developed by Japan-based Craif Inc., is based on the analysis of microRNA, small regulatory molecules that can be detected in urine. The company is investigating whether these molecular signals can provide a noninvasive way to identify cancer and other diseases.
Moving from development to clinical evidence
Pancreatic cancer is the initial focus of a planned prospective study at a newly opened laboratory in San Diego. The study is intended to generate additional clinical evidence as the technology moves toward US regulatory and reimbursement requirements.
The company reports that its flagship miSignal test is currently offered at more than 2,500 medical institutions and 4,500 pharmacies in Japan, with more than 110,000 tests performed to date. It also reports more than 90 peer-reviewed papers and conference presentations, including two independent publications demonstrating early and accurate detection of pancreatic cancer.
The US clinical effort will be led by Nicholas (Nick) Bevins, MD, PhD, who was recently appointed chief medical officer. Bevins is a board-certified clinical pathologist and has served as both a chief medical officer and CLIA laboratory director at biotechnology and diagnostics companies.
“I joined Craif because the company has built a differentiated platform, generated an extraordinary body of clinical evidence in Japan, and is committed to advancing science through rigorous data rather than hype,” Bevins said in a press release. “Urine will play an increasingly important role in the future of early disease detection because it offers a non-invasive window into human biology.”
The company opened its San Diego bio-AI laboratory in April and is advancing partnerships with 30 medical institutions across 15 states. It is also pursuing a Japanese regulatory filing for a software-based medical device program targeting pancreatic cancer diagnosis.
“We started Craif in 2018 to solve cancer, a problem the whole world shares, with technology built in Japan,” said Ryuichi Onose, CEO and cofounder, in a press release. “The earliest signals of many diseases show up in urine, and reading them is what Craif is really about. Cancer is the first step.”
The company’s approximately $33 million Series D financing will support US research and development and clinical work. The prospective study will provide an opportunity to further evaluate whether urinary microRNA analysis can contribute to pancreatic cancer diagnosis in a US clinical setting.
Note: This news summary was generated by AI based on a published press release, followed by a review from human editors.
