The Food and Drug Administration (FDA) has granted a submission for a Breakthrough Device designation from Prescient Metabiomics for its LifeKit Prevent Colorectal Neoplasia Test for the early detection of colon polyps and colon cancer.
The designation expedites the review process for medical devices that meet the Breakthrough Device Program (BDP) criteria and offers more effective diagnosis of life-threatening diseases and conditions. The program offers manufacturers the opportunity to collaborate with FDA experts to address topics during the pre-market review phase.
"We are excited to deliver LifeKit Prevent, a non-invasive diagnostic test that not only will aid in detecting colorectal cancer (CRC), but also help identify patients at risk for advanced adenomas," Keri Donaldson, MD, and chief executive officer of parent company Prescient Medicine Holdings, Inc., said in a press release. "By identifying patients most at risk for precancerous lesions, we can stop cancer before it starts and save lives."
The LifeKit Prevent test utilizes metagenomics technologies to identify microbial DNA and RNA biomarkers related to neoplasia in the lower gastrointestinal tract.