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 and specificity higher than 90%, according to the release.
“I have dedicated my career to the care of patients across the disease spectrum from BE, with and without dysplasia, to lethal esophageal cancer, and have participated in some of the key developments in this field,” Nicholas J. Shaheen, MD, MPH, chief of the division of gastroenterology and hepatology at University of North Carolina HealthCare, said in the release. “I am very excited that the FDA deemed EsoGuard worthy of Breakthrough Device designation. This recognition significantly enhances EsoGuard’s potential to prevent deaths from esophageal cancer through early detection of these conditions.”
Shaheen is the lead investigator on two studies that will compare EsoGuard with the gold standard of endoscopy and biopsy. The first, a screening study, will include patients with GERD without a prior diagnosis of BE or EAC, and the second will be a case-control study of patients with a previous diagnosis of either BE, dysplastic BE or EAC.
Disclosure: Healio Gastroenterology and Liver Disease could not confirm Shaheen’s relevant financial disclosures prior to publication.