Lucid Diagnostics submits clinical evidence for EsoGuard Esophagea DNA test

Lucid Diagnostics (LUCD), a subsidiary of PAVmed (PAVM), announced that it has submitted its complete clinical evidence package for its EsoGuard Esophageal DNA Test in support of a Request for Reconsideration of Local Coverage Determination, or LCD, L39256 “MolDX: Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia” to Molecular Diagnostics Program, or MolDX, administered by Palmetto GBA, a Medicare Administrative Contractor, or MAC, for the Centers for Medicare & Medicaid Services, or CMS, to seek coverage for EsoGuard. The EsoGuard clinical evidence package includes six new peer-reviewed publications: three clinical validation studies, two clinical utility studies, and one analytical validation study. The current LCD provides clear coverage criteria consistent with the American College of Gastroenterology (ACG) guidelines for esophageal precancer testing. The package was submitted as part of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard.