Exact Sciences Corp. in collaboration with Mayo Clinic Comprehensive Cancer Center, 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. with incidence having increased significantly over the past few decades compared to other, more common types of cancer where rates have either declined or remained flat due to advanced technologies in screening. The majority of EAC cases are diagnosed in advanced stages, with early EAC typically having no signs or symptoms, making screening in high-risk populations a critical need.

There are approximately 30 million people in the U.S. who are at high-risk for EAC and should be screening. 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 (MDMs).

Cross-validation of the three-MDM panel demonstrated an overall sensitivity of 82% (CI, 68% to 94%) for BE detection at 90% specificity (CI, 79% to 98%) in the training set and 88% sensitivity (CI, 78% to 94%) at 84% specificity (CI, 70% to 93%) in the test set. In both training and test sets, sensitivity was 100% for EAC and BE with high grade dysplasia (HGD) - both treatment-eligible subsets. The collection method was generally well tolerated by study participants and was conducive to office-based implementation.

The Oncoguard Esophagus test is currently under development and features of the test described above are outlining current development goals. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA) or any other national regulatory authority. Mayo Clinic and Dr. Iyer have a financial interest in the technology referenced in this press release.

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