Lucid Diagnostics announces data from ESOGUARD BE-1 study of EsoGuard

Lucid Diagnostics (LUCD), a majority-owned subsidiary of PAVmed (PAVM), 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 and esophageal adenocarcinoma 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 BE1 manuscript reports EsoGuard performance in 93 subjects who met criteria for esophageal precancer screening based on American College of Gastroenterology guidelines. 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%.