The FDA has given breakthrough device designation to the EsoGuard Esophageal DNA Test designed to help identity patients at higher risk for dysplasia due to chronic GERD, according to a press release from Lucid Diagnostics.The EsoGuard test is used on samples collected with Lucid’s EsoCheck device. The test performs next generation sequencing of bisulfate-converted DNA to detect methylation at 31 sites on two genes, VIM and CCNA1. A previous study comprising 408 patients found the test to be accurate at detecting Barrett’s esophagus and esophageal adenocarcinoma with a sensitivityRead More