Lucid Diagnostics Inc. and PAVmed Inc. announced positive data from its ESOGUARD BE-1 prospective, international, multicenter, single-arm study conducted to clinically validate performance of the EsoGuard® Esophageal DNA test on samples collected with the EsoCheck® Esophageal Cell Collection Device for detection of esophageal precancer (Barrett's Esophagus or BE) and esophageal adenocarcinoma (EAC) in a screening population. This is the second clinical validation study in a screening population following previously announced positive data from the Cleveland VA screening study, which was recently accepted for peer-reviewed publication. The ESOGUARD BE-1 study was led by Nicholas J. Shaheen, M.D., M.P.H., Professor of Medicine and Epidemiology at the University of North Carolina School of Medicine, a leading esophageal precancer expert and lead author of the American College of Gastroenterology (ACG) guidelines on esophageal precancer screening.

Study sites included leading academic medical centers, such as Baylor College of Medicine, University of California-Irvine, Vanderbilt University, and University of Utah, as well as other notable U.S. and European centers. The manuscript entitled Use of the EsoGuard® Molecular Biomarker Test in Non-Endoscopic Detection of Barrett's Esophagus among High-Risk Individuals in a Screening Population demonstrated high sensitivity and negative predictive value (NPV) compared to upper gastrointestinal endoscopy and is currently available on the leading health sciences preprint server, MedRxiv, pending peer review and publication. The manuscript for the Cleveland VA screening study, entitled Non-endoscopic screening for Barrett's esophagus and Esophageal Adenocarcinoma in at risk Veterans, has been accepted for peer-reviewed publication in the American Journal of Gastroenterology.

The BE1 manuscript reports EsoGuard performance in 93 subjects who met criteria for esophageal precancer screening based on American College of Gastroenterology (ACG) 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), underwent EsoCheck cell collection, had binary EsoGuard results, and a definitive final diagnosis established by upper gastrointestinal endoscopy and biopsies. Of these 93 subjects contributing to the primary endpoint analysis, eight had BE without dysplasia, for a disease prevalence of 8.6%. No subjects with EAC were identified.

EsoGuard sensitivity for BE was 87.5%, specificity was 81.2%, positive predictive value was 30.4%, and negative predictive value was 98.6%.