New FDA-approved device will help detect Barrett’s esophagus
CLEVELAND, U.S.: Researchers at Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center are celebrating the 510(k) clearance from the Food and Drug Administration (FDA) of their swallowable device used to detect Barrett’s esophagus (BE). The researchers report a 90% BE detection rate with the use of the device and it is therefore a significant step forward in diagnosis. Funding of $18 million has been awarded to develop the device.
Speaking about the research, Prof. Amitabh Chak said, “Symptoms of Barrett’s esophagus, such as heartburn, can also be commonly seen in individuals who have acid reflux disease without BE. These symptoms can easily be treated by over-the-counter medications so people often don’t get tested for BE, particularly by an invasive test such as endoscopy. As a result, when individuals develop EAC [esophageal adenocarcinoma], 95% of the time the presence of the prior Barrett’s esophagus was undetected and unknown. We wanted an easier, less costly test that could provide a practical way for screening and early detection of individuals with BE, who can then be followed closely to prevent development of EAC.”
To test for BE, patients need to ingest a small balloon-type device that is about the size of a tablet. After delivery to the stomach, it is inflated by injecting air through a thin catheter that the device is attached to. The inflated balloon is then maneuvered to swab the lower esophagus near the stomach, before being deflated by use of the catheter and retrieved through the mouth. After retrieval, the balloon, which is inverted back into the capsule in order to protect it from dilution or contamination, is tested for DNA abnormalities.
Going through such a process may be uncomfortable for some people. However, according to the research, 82% of the participants reported little to no anxiety, pain or choking; 93% stated that they would repeat the procedure; and 95% said that they would recommend the test to others.
The academic medical center is fortunate to be the only one in the country to which the National Institutes of Health have awarded funding from both the Specialized Program of Research Excellence in Gastrointestinal Cancer and the Barrett’s Esophagus Translational Research Network program. The FDA-approved device will be manufactured by Lucid Diagnostics and marketed under the tradename EsoCheck. The release date is still to be confirmed.
The study, titled “Identifying DNA methylation biomarkers for non-endoscopic detection of Barrett’s esophagus,” was published on Jan. 17, 2018, in Science Translational Medicine.