MADISON, Wis. - Exact Sciences Corp. (NASDAQ:EXAS), in partnership with the Mayo Clinic Comprehensive Cancer Center, has announced promising results from a study on a new, non-endoscopic test for detecting esophageal adenocarcinoma (EAC) and its precursors. The test, known as Oncoguard Esophagus, is being developed to offer a less invasive screening alternative for a type of cancer that is often diagnosed in later stages due to the absence of early symptoms.
The study focused on the test's ability to identify EAC and Barrett's esophagus (BE), a precursor to EAC. Using a sponge collection device, esophageal specimens were collected from 352 participants in a training set and 125 in a test set. The specimens were then analyzed for methylated DNA markers (MDMs).
The results showed 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. Notably, the test demonstrated 100% sensitivity for EAC and BE with high-grade dysplasia, both of which are eligible for treatment.
According to Dr. Prasad G. Iyer from the Mayo Clinic, the test represents a significant step towards accurate, non-endoscopic detection of BE/EAC. Paul Limburg, Chief Medical Officer of Screening at Exact Sciences, emphasized the company's commitment to providing accurate, less invasive, and cost-effective screening options.
The Oncoguard Esophagus test is still under development and has not yet been cleared or approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. The study's results were recently published in the Clinical Gastroenterology and Hepatology journal.
As part of the development process, Exact Sciences is working to validate the test's performance characteristics and healthcare benefits in a commercial setting. The company has a history of developing cancer screening and diagnostic tests, including the Cologuard and Oncotype tests.
This news, based on a press release statement, is particularly relevant for the estimated 30 million people in the U.S. who are at high risk for EAC and could benefit from earlier and less invasive screening methods. Exact Sciences and Dr. Iyer from Mayo Clinic have financial interests in the technology, which the clinic plans to use in supporting its non-profit mission in patient care, education, and research.
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