The FDA has granted investigational device exemption to medical diagnostics company Check-Cap for a two-part pivotal study to evaluate C-Scan, a new screening test that detects precancerous polyps.
“There is a serious unmet need for a patient-friendly screening option that can overcome screening barriers while also enabling precancerous polyp detection. Most patient-friendly [colorectal cancer (CRC)] screening tests currently available or poised to enter the market, such as liquid biopsy or fecal tests, are primarily designed to detect cancer.