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CE Marking Tamilnadu

Check-Cap files for CE Mark certification for C-Scan; shares ahead 7%

  • Ultra-thinly traded nano cap Check-Cap (CHEK +7.3%) has filed for CE Mark registration for ingestible colorectal cancer screening device C-Scan.
  • The data supporting the submission was generated in a study designed to assess C-Scan’s ability to detect polyps. The results showed 44% sensitivity (properly recognizing true positives) and 89% specificity (correctly identifying true negatives) in 45 subjects.
  • Sensitivity strongly correlated with the percentage of the colon scanned, 100% when at least 70% of the colon was scanned and 78% when at least half the colon was scanned. Specificity was consistent throughout.
  • In a note, Maxim Group says it is “worried” that the 44% sensitivity is too low, but it can progress with better software. It expects the CE Mark to be issued.
  • Source: Bloomberg

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