Israeli medical diagnostics company Check-Cap (Nasdaq: CHEK) has announced positive final results from its recently completed post-CE approval study evaluating the clinical performance and safety of the C-Scan system. C-Scan is a preparation-free capsule based screening method for the prevention of colorectal cancer through the detection of precancerous polyps.
The multi-center, home monitoring study was designed to determine the performance characteristics of Check-Cap's C-Scan capsule-based screening test compared with the commonly used fecal immunochemical colorectal cancer screening test (FIT). In each case colonoscopy was used as the reference method.
The study included 90 patients who either had known polyps or were considered to be of average risk. Each patient swallowed a C-Scan capsule and also underwent a FIT and a comparative colonoscopy performed by independent gastroenterologists, who were blinded to the corresponding test's results.
The primary efficacy endpoint of the study was the ability to correctly identify patients with polyps and the patients without polyps of the C-Scan system compared with FIT. C-Scan identified 76% of patients with polyps while FIT identified 29%. C-Scan identified 82% of patients without polyps, while FIT identified 96%..
In addition, C-Scan detected all 4 patients with larger polyps (over 40mm) while the FIT detected only 1 of the 4 patients. C-Scan achieved an accurate diagnosis in 66% of all patients, compared with 23% for FIT. No serious adverse events were reported, and the adverse events were mild in severity.
Check-Cap CEO Alex Ovadia said, "We are delighted to share the results from the post-CE approval study which continue to validate the importance and potential of the C-Scan system. Completing this study on a larger sample is an essential milestone in the development and commercialization process of the C-Scan system in the US and worldwide, as it provides us with additional insight for a US pivotal study, which we plan to be initiate during 2020."
Check-Cap is currently conducting a pilot study in the US to evaluate the safety, usability and subject compliance of the C-Scan system at the New York University School of Medicine and Mayo Clinic.
The C-Scan system has received CE marking and approval from the Israeli Ministry of Health, the Medical Device Division (AMAR) for marketing in Israel.
Published by Globes, Israel business news - en.globes.co.il - on July 11, 2019
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