The FDA granted Check-Cap's C-Scan an investigational device exemption March 15 that will allow the test to launch a clinical study in the U.S.
The C-Scan test is a capsule-based screening technology used to detect polyps before they turn into cancer. The test uses an ultralow-dose X-ray capsule and a proprietary software system to generate a map of the inner lining of the colon as it travels through the gastrointestinal tract. The test requires no bowel preparation and is noninvasive. The test, however, is not a colonoscopy replacement and all positive C-Scan tests should be followed by a colonoscopy.
Check-Cap will soon launch a U.S.-based trial late this year to evaluate test performance in average-risk individuals.
Alex Ovadia, CEO of Check-Cap, said, "We believe that this highlights the FDA's recognition of C-Scan as an alternative method to address the significant unmet need for patient-friendly CRC screening, in particular since it enables the detection of CRC polyps before they may turn into cancer."
News of the approval boosted the company's stock price from around $1.50 to $4.04 at market open March 15.