PAVmed’s (NASDAQ:PAVM) subsidiary, Lucid Diagnostics, received FDA breakthrough device designation for its EsoGuard esophageal DNA test.
The EsoGuard test, which is performed on esophageal samples collected using Lucid’s FDA-cleared EsoCheck device, is designed to facilitate the diagnosis of Barrett’s esophagus (BE) and esophageal cancer (EAC) in patents with gastroesophageal reflux disease (GERD).
In the coming weeks, Lucid expects to begin enrolling patients at some 60 sites across the U.S. and Europe to conduct studies to support FDA premarket approval. The studies will compare EsoGuard with the standard of endoscopy with biopsies in GERD patients with and without a prior diagnosis of BE or EAC.
“This designation validates our belief that EsoGuard is a groundbreaking technology that has the potential to have as great an impact on esophageal cancer as widespread pap screening has had in preventing deaths from cervical cancer,” Dr. Lishan Aklog, PAVmed’s chairman and CEO, and Lucid’s executive chairman, said in a statement.
