Check-Cap seeks approval for C-Scan capsule for colon cancer screening in Europe

Medical diagnostics company Check-Cap announced it has filed for CE Mark registration for C-Scan, an ingestible capsule for preparation-free colorectal cancer screening.

C-Scan uses low-dose X-ray and wireless technology to map the colon as it naturally passes through, allowing physicians to screen for polyps and abnormalities without the need for bowel prep or sedation, according to a press release.

The CE Mark submission is supported by data from a multicenter clinical trial demonstrating C-Scan’s safety and “encouraging results for detecting patients with polyps in an un-prepped colon.”

In the study, researchers evaluated 66 participants (mean age, 59 years) enrolled at three centers who ingested a C-scan capsule, after which they ingested small doses of contrast agent and fiber supplements with normal meals during the capsule’s transit (mean transit time, 52 ± 32 hours).

The process required an average total X-ray dose of 0.05 mSv; for comparison, the press release noted that the effective X-ray dose for CT colonography is about 6 mSv.

An independent investigator performed confirmatory colonoscopy, and a central group reviewed C-Scan results, both of whom were masked to results.

Among 45 participants analyzed for polyp detection, C-Scan performed with 44% sensitivity and 89% specificity. While specificity was similar across all participants, sensitivity was strongly correlated with the proportion of colon scanned, and increased to 78% when more than 50% of the colon was scanned, and to 100% when more than 70% of the colon was scanned (both P < .05).

“These clinical results demonstrate C-Scan’s positive safety profile and strong correlation between detection of patients with polyps and capsule scan coverage,” Nadir Arber, MD, study investigator, professor of internal medicine and gastroenterology, and head of the Health Promotion Center and Integrated Cancer Prevention Center at Tel-Aviv Sourasky Medical Center, said in the press release. “Top line accuracy results are rather encouraging as well, as the sensitivity for advanced adenomas by stool testing, the primary colorectal cancer screening test in EU, demonstrates sensitivity ranges of 22% to 40%.”

Because C-Scan is non-invasive and requires no bowel prep, sedation, or diet changes, the improved patient experience could boost CRC screening rates if approved, according to the press release.

“Despite evidence suggesting that polyp detection and removal can decrease CRC incidence and mortality, screening adherence remains disappointingly low,” Arber said. “Many patients are unwilling to choose standard tests due to unpleasant bowel preparation requirements or stool collection. The promise of C-Scan is to provide a more patient-friendly option which could potentially increase screening rates. We look forward to additional research evaluating C-Scan for colonic polyp detection.”

“Our system was shown to be safe and capable of identifying polyps for removal in patients with no bowel preparation,” Bill Densel, CEO of Check-Cap, said in the press release. “We are underway with the clinical evaluation of our advanced C-Scan version, incorporating improvements to software algorithms. We are committed to developing an alternative to today’s invasive and preparation-intensive approaches to colorectal cancer prevention.”

The company expects a pilot trial in the U.S. to begin in the first half of 2018, he added.

Disclosures: Densel is employed by Check-Cap and Arber reports he is a scientific advisor for the company.