Swallowable Device to Detect Pre-cancerous Barrett's Esophagus Receives FDA 510(k) Clearance

Investigators at Case Western Reserve University School of Medicine, the Case Comprehensive Cancer Center and University Hospitals Cleveland Medical Center developed the test for early detection of Barrett’s esophagus that offers promise for preventing deaths from esophageal adenocarcinoma.

The test involves a novel swallowable balloon device that samples the esophagus and a DNA assay that detects Barrett’s esophagus and esophageal cancers. In a major step to bringing this technology forward to patients, the balloon device has just received 510K clearance from the U.S. Food and Drug Administration (FDA) for clinical use. The now FDA-cleared device is being manufactured by Lucid Diagnostics and marketed under the tradename EsoCheck.

The device was developed by School of Medicine faculty and University Hospital physicians Amitabh Chak, MD, Joseph Willis, MD, and Sanford Markowitz, MD, PhD, all of whom are members of the Case Comprehensive Cancer Center.

Barrett’s esophagus (BE) is the precursor lesion of esophageal adenocarcinoma (EAC), a highly lethal cancer with more than 80% mortality at five years. Lethal EAC can be prevented when patients are diagnosed at the precursor stage of BE, and early foci of near cancerous changes (dysplasias) are ablated. However, detection of BE has traditionally necessitated endoscopy, an expensive and invasive test that requires sedation and is thus unsuitable as a method for wide BE screening.

In a significant step forward, the investigator team developed an easy, five-minute outpatient test that is more than 90% sensitive for detecting individuals with BE. Patients simply swallow a pill-sized capsule attached to a thin silicone catheter. After delivery to the stomach, the small balloon inside the capsule, is inflated by injecting air through the catheter. The inflated balloon is maneuvered to swab the lower esophagus near the stomach, the region where BE begins, and obtain a sample of the lining cells. Surface texturing on the balloon increases the effectiveness of the sampling. The balloon is then deflated through the catheter and inverted back into the capsule, thus protecting the esophagus sample from dilution or contamination.

After easy retrieval of the capsule through the mouth, DNA is extracted from the balloon surface and tested for aberrant DNA methylation that the investigators discovered is diagnostics of BE.

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