As Lucid Diagnostics’ commercial diagnostic laboratory partner, the new EsoGuard esophageal DNA laboratory-developed test (LDT) was developed and completed CLIA and CAP certification at ResearchDx’s premier molecular laboratory, PacificDx.
The first of its kind, this non-invasive DNA test was designed to detect the presence of dysplastic and non-dysplastic Barrett’s Esophagus (BE) and esophageal adenocarcinoma (EAC) with of an accuracy greater than 90%. Performed at PacificDx, the EsoGuard LDT employs real-time PCR, next generation sequencing (NGS) and a complex bioinformatics algorithm to determine the methylation status of 31 sites on the Vimentin (VIM) and CyclinA1 (CCNA) genes—testing is performed on preserved cells sampled from the distal lining of the esophagus. Positive results have been associated with dysplastic and non-dysplastic BE as well as EAC. Often asymptomatic in patients with chronic gastroesophageal reflux disease (GERD), BE with or without dysplasia can progress to EAC undetected. For chronic GERD patients, early screening and detection of BE may prevent progression to EAC, a lethal cancer that carries a 5-year survival rate of 20%.
Find out more about the EsoGuard LDT, Lucid Diagnostics, and PAVmed, Lucid’s parent company who specializes in novel, innovative medical products such as EsoCheck—a non-invasive device for collecting cells from the lining of the esophagus.