Pavmed (NSDQ:PAVM) recently announced that its Lucid Diagnostics subsidiary has received FDA breakthrough device designation for its EsoGuard esophageal DNA test.
The test uses esophageal samples collected using Lucid’s 510(k)-cleared EsoCheck cell collection device from certain patients at elevated risk for esophageal dysplasia due to chronic gastroesophageal reflux disease (GERD). EsoGuard and EsoCheck are designed to facilitate the diagnosis of Barrett’s esophagus with and without dysplasia — a progression of precursor conditions that culminate in highly lethal esophageal cancer (EAC) — as well as EAC itself, in patients with chronic heartburn.