FDA approves IDE application for novel polyp detection test
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The FDA has granted investigational device exemption to medical diagnostics company Check-Cap for a two-part pivotal study to evaluate C-Scan, a new screening test that detects precancerous polyps.
“There is a serious unmet need for a patient-friendly screening option that can overcome screening barriers while also enabling precancerous polyp detection. Most patient-friendly [colorectal cancer (CRC)] screening tests currently available or poised to enter the market, such as liquid biopsy or fecal tests, are primarily designed to detect cancer. As such, they do not necessarily provide patients with the time window to pre-empt the disease,” Yoav Kimchy, PhD, founder and chief technology officer of Check-Cap, told Healio. “C-Scan is a noninvasive, capsule-based, preparation-free CRC screening test that aims to address issues associated with low adherence to preventive screenings with colonoscopies. We believe C-Scan could change the face of CRC screening and prevention in the future by offering a more patient-friendly option that can detect polyps before they may turn into cancer.”
According to a company press release, the software uses a low-dose X-ray capsule and recording system to generate a 3D map of the inner lining of the colon along the GI tract. A positive result should be followed by colonoscopy.
“Now that we have received approval from the FDA of our amended protocol, we are focused on final preparations to initiate the first part of the U.S. pivotal study, which we anticipate will begin in March-April 2022, followed by initiation of the second part of the study in Q4 2022,” Alex Ovadia, CEO of Check-Cap, said in the release. “Initiation of the study signifies a major step in the clinical development of our device, which is designed to detect precancerous polyps.”
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