Check-Cap seeks CE Mark for C-Scan diagnostic capsule

Check-Cap (NSDQ:CHEK) said today that it filed for CE-Mark registration of its C-Scan ingestible capsule, designed for preparation-free, colorectal cancer screening.

Data used to support the EU regulatory submission showed that C-Scan had a 44% sensitivity in the 45 study participants included in an analysis for polyps, with 89% specificity. The company reported that sensitivity strongly correlated to the percentage of the colon scanned – sensitivity was 78% and 100% for participants where greater than 50% and 70% of the colon was scanned, respectively.

The 66 patients enrolled in the trial ingested the capsule and swallowed small doses of contrast agent and fiber supplements with each meal. The average capsule transmit time was 52 hours (+/- 32 hours) and the average total X-ray dose was 0.05 mSv, compared to the 6.0 mSv associated with a CT colongraphy.

No bowel prep or sedation was required, Check-Cap noted, unlike a traditional colonoscopy.

“These clinical results demonstrate C-Scan’s positive safety profile and strong correlation between detection of patients with polyps and capsule scan coverage. 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%,” principal investigator Nadir Arber said in prepared remarks.

“Despite evidence suggesting that polyp detection and removal can decrease CRC incidence and mortality, screening adherence remains disappointingly low. 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.”

“Submission of the CE Mark application marks an important milestone for Check-Cap, and we are pleased with the achievements made in the clinical performance of C-Scan, as demonstrated in the multi-center, comparative trial. Our system was shown to be safe and capable of identifying polyps for removal in patients with no bowel preparation. We are underway with the clinical evaluation of our advanced C-Scan version, incorporating improvements to software algorithms,” Check-Cap CEO Bill Densel added.

“We are committed to developing an alternative to today’s invasive and preparation-intensive approaches to colorectal cancer prevention. We look forward to EU post market initiation and US pilot trial, expected to begin in the first half of 2018.”

See the best minds in medtech live at DeviceTalks Boston on Oct. 2. 

The post Check-Cap seeks CE Mark for C-Scan diagnostic capsule appeared first on MassDevice.

from MassDevice http://ift.tt/2wjVxxa