Lucid Diagnostics (NASDAQ:LUCD) announced positive results from its clinical validation study of EsoGuard Esophageal DNA test on samples collected from patients with Barrett’s Esophagus (BE) and esophageal adenocarcinoma (EAC) using its EsoCheck Esophageal Cell Collection Device.
The prospective screening study demonstrated EsoGuard sensitivity of 87.5% and a negative predictive value of 98.6%. The study is the second of its kind in a screening population and follows previously announced positive data from a Cleveland VA screening study, which was accepted for peer-reviewed publication.
In a statement, Victoria T. Lee, M.D., and CMO of Lucid, said, “As previously reported, three published clinical utility studies have already documented that physicians consistently utilized EsoGuard results to appropriately triage at-risk patients, which can result in more cost-effective utilization of endoscopy for esophageal precancer detection. These clinical validation and clinical utility data, coupled with multiple national society guidelines and consensus statements supporting non-endoscopic esophageal precancer detection, provide a robust clinical evidence base in support of our upcoming Medicare LCD pre-submission meeting and ongoing commercial payor engagements.”
