Exact Sciences Corp., which provides cancer screening and diagnostic tests, in collaboration with Mayo Clinic Comprehensive Cancer Center, reported on data showing high sensitivity for a non-endoscopic Oncoguard Esophagus test, currently in development. The test works to detect esophageal adenocarcinoma (EAC) and its precursors, including Barrett’s esophagus (BE).
EAC is the most common form of esophageal cancer in the U.S. with incidence having increased significantly over the past few decades. The majority of EAC cases are diagnosed in advanced stages, with early EAC typically having no signs or symptoms. There are approximately 30 million people in the U.S. who are at high risk for EAC and should be screened.
The study used an encapsulated sponge collection device to collect esophageal specimens from 352 participants in the training set and 125 participants in the test set. These were then blindly assayed for methylated DNA markers. The collection method was generally well tolerated by study participants and was conducive to office-based implementation.
The Oncoguard Esophagus test has not been cleared or approved by the U.S. Food and Drug Administration or any other national regulatory authority.
