Exact Sciences’ Oncoguard Esophagus test shows efficacy in published study

Exact Sciences reported on data showing high sensitivity and specificity for the non-endoscopic Oncoguard Esophagus test that is currently in development for the detection of esophageal adenocarcinoma – EAC – and its precursors, including Barrett’s esophagus – BE -. Findings from the test’s algorithm training and testing were recently published in the Clinical Gastroenterology and Hepatology journal. EAC is the most common form of esophageal cancer in the U.S. The majority of EAC cases are diagnosed in advanced stages. Cross-validation of the three methylated DNA markers panel demonstrated an overall sensitivity of 82% for BE detection at 90% specificity in the training set and 88% sensitivity at 84% specificity in the test set. In both training and test sets, sensitivity was 100% for EAC and BE with high grade dysplasia. The collection method was generally well tolerated by study participants and was conducive to office-based implementation. This test has not been cleared or approved by the FDA or any other national regulatory authority.