Israeli clinical-stage medical diagnostics company Check-Cap Ltd. (Nasdaq: CHEK) today announced the result of a trial of its product - a capsule designed to replace a colonoscopy for colorectal cancer detection. The product has already been approved for marketing in Europe; the trial is aimed at supporting its marketing.
The share price of Check-Cap, whose market cap is $21 million, is up 7% in preliminary trading.
31 subjects took part in the trial. The pill detected polyps in 76% of the cases in which a polyps was present and correctly detected the absence of a polyps in 80% of the cases in which there was none. These figures are slightly lower than the existing figures in the literature for the accuracy and specificity of a conventional colonoscopy, but the test is designed for those unable or unwilling to undergo a colonoscopy.
In any case, these results are a significant improvement over the results from an earlier version of the company's product, for which the detection rate was 44%.
Check-Cap CEO Alex Ovadia said, "We are excited to unveil the multidimensional screening capabilities of the C-Scan system. We believe that the encouraging interim results from our ongoing post CE approval study demonstrate a significant progress in the clinical performance of C-Scan compared with previously communicated CE study results for our patient-friendly, and preparation free colon-cancer screening device." "These results were achieved through the continuous improvements in cross-system algorithms, while maintaining C-Scan's strong safety profile. As our post CE approval study continues, with final results planned in the second quarter of 2019 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 US pilot trial in the fourth quarter of 2018."
Published by Globes [online], Israel business news - www.globes-online.com - on September 4, 2018
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