The U.S. Food and Drug Administration (FDA) has granted investigational device exemption for Check-Cap's C-Scan, permitting the company to study the polyp screening test in the U.S.
C-Scan aims to detect colorectal polyps before they turn into cancer. It is intended for screening of individuals who are at average risk for colorectal cancer and are poor candidates for colonoscopy or decline colonoscopy, or who had incomplete optical colonoscopies.
The study will evaluate the safety and performance of C-Scan, as well as patient compliance with the test. C-Scan is based on an ultralow-dose x-ray capsule and control and recording system that generates a 3D map of the inner lining of the colon as it travels through the gastrointestinal tract.