Medical diagnostics company Check-Cap Ltd (NASDAQ:CHEK) (NASDAQ:CHEKW), (NASDAQ:CHEKZ) reported on Thursday the receipt of the US Food and Drug Administration's (FDA) conditional approval for its Investigational Device Exemption (IDE) application for the initiation of a US pilot study of the C-Scan system.

The company added that the C-Scan is the first and only preparation-free capsule-based screening method for the prevention of colorectal cancer (CRC) through the detection of precancerous polyps. The system utilizes an ultra-low dose X-ray capsule, an integrated positioning, control, recording system, as well as proprietary software to generate a 3D map of the inner lining of the colon. It is non-invasive and requires no preparation or sedation, allowing the patient to continue their daily routine.

Following approval of the additional information to the US FDA, the company may begin enrolling patients immediately under the US pilot study (NCT03735407), a single-arm study enrolling subjects of average risk for polyps and colon cancer. The study will evaluate the safety, usability and subject compliance of the C-Scan system.

CRC typically begins as precancerous polyps or abnormal growths in the colon or rectum, which can be present for up to 10 years before developing into invasive cancer. As a result, screening for precancerous polyps is the most direct method for CRC prevention.