EsoGuard DNA test receives breakthrough designation

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 sensitivity

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