Benzinga | Mar 15, 2021 07:35AM EDT

FDA Signs Off Check-Cap's Pivotal Study For Capsule-Based Colorectal Cancer Screening Technology

Check-Cap Ltd (NASDAQ: CHEK) stock is moving higher on heavy volume in the premarket session after the FDA approved its Investigational Device Exemption (IDE) application, permitting Check-Cap to begin a pivotal study of C-Scan in the U.S.

* C-Scan is the company's capsule-based screening technology to detect polyps before they may transform into colorectal cancer (CRC) to enable early intervention and cancer prevention.

* The pivotal study will evaluate C-Scan's safety and performance and is expected to start in late 2021.

* In parallel, the company will initiate a study in Israel and enroll up to 250 average-risk patients.

* Additionally, updated CRC screening guidelines from the American College of Gastroenterology published in March 2021 recommend colon capsules as an option for CRC screening in people who are either unwilling or unable to undergo a colonoscopy or Fecal Immunochemical Test.

* Price Action: CHEK stock has gained 122.2% at $3.40 in premarket trading on the last check Monday.