FDA Clears Pavmed’s Esophageal DNA Diagnostic

The FDA granted Pavmed’s Lucid Diagnostics subsidiary breakthrough device designation for its EsoGuard esophageal DNA test.

The test analyzes esophageal samples taken using the company’s EsoCheck cell collector from patients at higher risk of esophageal dysplasia due to chronic gastroesophageal reflux disease.

The diagnostic screens for modifications at 31 sites on two genes using next generation sequencing of the DNA, the company said.