Lucid Diagnostics Inc. announced that investigators at the Louis Stokes Cleveland Veterans Affairs Medical Center, led by Katarina B. Greer, M.D.,M.S., Associate Professor of Medicine at Case Western Reserve University School of Medicine, have released data from a Department of Defense funded prospective clinical validation study of patients who met strict national society guideline criteria for esophageal precancer testing. The study demonstrated excellent performance of Lucid's EsoGuard®? Esophageal DNA test for esophageal prec Cancer detection and is the first to present such clinical validity data in a screening population.

The manuscript entitled Non-endoscopic screening for Barrett's esophagus and Esophageal Adenocarcinoma in at risk Veterans is available on the leading health sciences preprint server, medRxiv, pending peer review and publication. Collectively, these three clinical validity studies demonstrate excellent EsoGuard sensitivity and negative predictive value, including unprecedented performance of a molecular diagnostic test in detecting a preprint. They strongly support EsoGuard's use as a widespread screening tool to prevent esophageal cancer through the early detection of esophageal precancer.

Physicians consistently utilized EsoGuard results to appropriately triage at-risk patients resulting in more cost-effective utilization of endoscopy for esophageal prec cancer detection. The clinical validity and clinical utility data, coupled with multiple national society guidelines and consensus statements supporting EsoGuard medical policy coverage and a line of sight to CMS coverage, in particular. The manuscript reports on 128 eligible patients with no prior history of upper gastrointestinal endoscopy (EGD) who met criteria for esophageal prepancer screening based on current American College of Gastroenterology guidelines (presence of chronic heartburn and at least three of six additional risk factors--age over 50 years, male sex, white race, obesity, smoking and positive family history).

124 patients underwent successful non-endoscopic esophageal cell sampling using the EsoCheck®? Cell Collection Device followed by EGD.