Clinical stage medical diagnostics company Check-Cap received approval from the FDA for its amended Investigational Device Exemption application for C-Scan, allowing for a U.S. pivotal study.
Check-Cap's goal is to innovate colorectal cancer screening. The company's preparation-free screening test, C-Scan, allows physicians to detect polyps before they become colorectal cancer, according to a Feb. 7 press release. C-Scan is noninvasive and doesn't require sedation or bowel preparation. It uses an X-ray capsule with an ultra-low dose, along with integrated positioning. It has a control and recording system and proprietary software to generate a 3D map of the inner lining of the colon while it travels along the gastrointestinal tract.
Check-Cap CEO Alex Ovadia said: "Now that we have received approval from the FDA of our amended protocol, we are focused on final preparations to initiate the first part of the U.S. pivotal study, which we anticipate will begin in March-April 2022, followed by initiation of the second part of the study in Q4 2022. Initiation of the study signifies a major step in the clinical development of our device, which is designed to detect precancerous polyps."