Check-Cap gains on start of U.S. pivotal trial for cancer screening test

May 11, 2022 8:44 AM ETCheck-Cap Ltd. (CHEK)By: Dulan Lokuwithana, SA News Editor1 Comment

colorectal cancer word, medical term word with medical concepts in blackboard and medical equipment

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  • Check-Cap Ltd. (NASDAQ:CHEK) has added ~7% in the pre-market Wednesday after the clinical-stage medical diagnostics company announced the initiation of a U.S. pivotal trial for C-Scan, an investigational screening test to detect colorectal cancer.
  • The two-part open-label trial started at Mayo Clinic in Rochester Minnesota, is led by Elizabeth Rajan, gastroenterologist, and professor of medicine at Mayo Clinic, the company said.
  • The company has already obtained the approval of the Institutional Review Board (IRB) for the study, and the patient enrollment is expected to start shortly. The U.S.-based trial is expected to enroll about 1,000 subjects aged 50 – 75 years across 15 sites.
  • “…our plan is to complete the calibration portion of the trial and begin the second statistically powered portion of the study during Q4 2022," Chief Executive Alex Ovadia remarked.
  • In February, Check-Cap (CHEK) announced the regulatory clearance for the study.

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