Results from Check-Cap’s (NASDAQ:CHEK) post-CE approval study evaluating the screening performance of C-Scan to detect precancerous polyps in the colon showed much better performance compared to the fecal immunochemical test (FIT).
The data were generated from 90 patients who either had known polyps or were considered to be at average risk. Each ingested a C-Scan capsule in additional to undergoing a FIT test and colonoscopy.
In patients with polyps at least 10 mm in size, the sensitivity (correctly identifying true positives) of C-Scan was 76% compared to 29% for FIT. C-Scan’s specificity (correctly identifying true negatives) was 82% versus 96% for FIT in these patients.
In all patients, C-Scan’s sensitivity was 66% compared to 23% for FIT.
A U.S. pilot study is in process with an estimated completion date in September. A pivotal trial should launch in mid-2020.
Update: Shares are up 20% premarket on average volume.
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