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PAVmed Subsidiary Lucid Diagnostics Announces Commercial Launch of EsoGuard Esophageal DNA Test
First commercially available DNA test designed to facilitate the diagnosis of Barrett’s Esophagus and related precursors to highly lethal form of esophageal
About this update from Pavmed Inc.
[{"type":"text","content":"First commercially available DNA test designed to facilitate the diagnosis of Barrett’s Esophagus and related precursors to highly lethal form of esophageal cancer\n First patients to undergo testing today at gastroenterology center of excellence NEW YORK, Dec. 19, 2019 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today announced that its majority owned subsidiary, Lucid Diagnostics Inc. (“Lucid”) has launched its EsoGuard™ Esophageal DNA Test as a Laboratory Developed Test (LDT), after completing CLIA/CAP certification of the test at Lucid’s commercial diagnostic laboratory partner ResearchDx Inc. dba Pacific Dx (“ResearchDx”), headquartered in Irvine, CA. EsoGuard is the first such DNA test designed to facilitate the diagnosis of Barrett’s Esophagus (BE) and related precursors to highly lethal esophageal adenocarcinoma (EAC). “This major commercialization milestone is a testament to the hard work and dedication of the Lucid team, our world-class partners at ResearchDx and our innovative colleagues on the Case Western Reserve faculty,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer and Lucid’s Executive Chairman. “We created Lucid Diagnostics and licensed this groundbreaking technology to eradicate the scourge of deaths from esophageal cancer by detecting Barrett’s Esophagus in high-risk patients with chronic heartburn (GERD) early enough to permit careful surveillance and curative treatment. The commercial launch of EsoGuard LDT arms U.S. physicians with a highly accurate diagnostic tool to facilitate the noninvasive diagnosis of Barrett’s Esophagus and more advanced precursors to esophageal cancer.” 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, CA where the DNA is immediately extracted. The DNA is then subjected to bisulfite conversion, PCR amplification and next generation sequencing (NGS) to determine the methylation status of 31 sites on the Vimentin (VIM) and CyclinA1 (CCNA) genes. A complex bioinformatics 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 ...