Check-Cap, a clinical stage medical diagnostics company advancing the development of C-Scan, a screening test to detect polyps before they may transform into colorectal cancer (CRC), has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application, permitting Check-Cap to begin a pivotal study of C-Scan in the U.S.
C-Scan is intended for candidates who are at average-risk for CRC and who are poor candidates for colonoscopy or decline colonoscopy, or who had an incomplete optical colonoscopy. The pivotal study will evaluate safety and performance of C-Scan as well as subject compliance with C-Scan.
Alex Ovadia, chief executive officer of Check-Cap, said: "The IDE approval is a significant milestone for Check-Cap. Now with IDE in hand, we aim to enter the last phase of demonstrating the clinical potential of C-Scan in the U.S., with the ultimate goal of commercialisation in this important market. We are in active discussions with a number of clinical sites as part of our preparations to begin the pivotal study in late 2021. In parallel, as previously communicated, we will be continuing to optimise C-Scan's performance and patient experience through additional clinical data collection at Israeli sites. To this end, we are gearing up to initiate a study in Israel at more than 10 clinical sites to enrol up to 250 average risk patients.
"We are also pleased to announce that the FDA has approved the company's Breakthrough Device Designation for the intended use of identifying candidates within the average risk population who are at elevated risk for polyps equal to or larger than 1 cm and are poor candidates for colonoscopy. We believe that this highlights the FDA's recognition of C-Scan as an alternative method to address the significant unmet need for patient-friendly CRC screening, in particular since it enables the detection of colorectal polyps before they may turn into cancer.
“Additionally, updated CRC screening guidelines from the American College of Gastroenterology (ACG) published on March 2021, recommend colon capsules as an option for CRC screening in people who are either unwilling or unable to undergo a colonoscopy or Faecal Immunochemical Test (FIT). As screening for precancerous polyps provides an opportunity for early intervention and cancer prevention, C-Scan could be considered as an option for those individuals, if approved."
