PAVmed's Lucid Diagnostics subsidiary has launched its EsoGuard Esophageal DNA Test as a laboratory-developed test after completing CLIA/CAP certification of the test. EsoGuard is a DNA test designed to facilitate the diagnosis of Barrett's esophagus and related precursors to esophageal adenocarcinoma.
EsoGuard LDT is performed on cells which are noninvasively sampled from the distal esophageal lining and shipped in a custom preservative solution to the ResearchDx facility in Irvine, California, where the DNA is immediately extracted. The DNA is then subjected to bisulfite conversion, PCR amplification, and next-generation sequencing to determine the methylation status of 31 sites on the vimentin and cyclinA1 genes, the company said. A bioinformatic algorithm is 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.
A positive result has been associated with the presence of non-dysplastic Barrett's esophagus, dysplastic Barrett's esophagus, or esophageal adenocarcinoma, PAVmed added.