Clinical-stage medical diagnostics company Check-Cap (Isfiya, Israel) has received interim results for its post-CE Mark approval study of the third version of its C-Scan ingestible, capsule-based device for preparation-free colorectal cancer screening. Data from the multicenter clinical investigation showed promising results for detecting patients with polyps in an un-prepped colon.
The objective of the study is to assess safety and clinical performance of the system in detecting patients with polyps. In a recent multicenter study on 31 evaluable patients, the system (equipped with improved algorithms) demonstrated a sensitivity (ability to correctly identify polyps) of 76% (P=0.0038), with specificity (ability to correctly identify lack of polyps) of 80% for polyp detection, when using the full patient population with a gender-based analysis. Confirmatory colonoscopy and C-Scan system results analysis were performed by independent expert investigators who were blinded to corresponding tests' results.
Improvements to the system include better scan imaging density, 2D/3D imaging, and a new motility analysis algorithm that was recently tested on two years of continued clinical study data.
"As our post CE approval study continues, with final results planned in 2Q/19 on a more substantial number of patients, we look forward to delivering on our near-term milestones for the remainder of 2018 and forward, including the establishment of the GE manufacturing line and regulatory path in the United States towards the expected initiation of our U.S. pilot trial in 4Q/18," says Alex Ovadia, CEO of Check-Cap.
For more information, please visit www.check-cap.com.