NEW YORK – Lucid Diagnostics, a PAVmed subsidiary, said Thursday that it has received breakthrough device designation from the US Food and Drug Administration for a test to detect esophageal dysplasia and potential cancer risk.
Called the EsoGuard Esophageal DNA Test, the assay is meant to be performed on esophageal samples collected using the firm's EsoCheck Cell Collection Device in a well-defined group of patients at elevated risk for esophageal dysplasia due to chronic gastroesophageal reflux disease, or GERD.
The EsoGuard test involves bisulfite conversion, PCR amplification, and next-generation sequencing to determine the methylation status of 31 sites in the vimentin and cyclinA1 genes, as previously reported. An algorithm is then used to calculate the percentage of DNA molecules in which a proportion of methylated sites on either gene exceeds a certain threshold, delivering a positive or negative result.
"EsoGuard's FDA Breakthrough Device designation represents a major milestone for PAVmed and Lucid," said Lishan Aklog, PAVmed's chairman and CEO and Lucid's executive chairman, in a statement.
"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. We look forward to working closely with the FDA to advance our EsoGuard in vitro diagnostic clinical development program at an expedited pace," he said.
EsoGuard, which is already commercially available as a laboratory-developed test, is now the subject of two Lucid-sponsored international multi-center IVD clinical trials in support of an FDA pre-market approval, the firm said.