Non-Endoscopic Screening for Barrett's Esophagus Using a DNA Methylation-Based Assay: 18-Month Real-World Experience in 11,991 Patients

BackgroundBarretts esophagus (BE), characterized by specialized intestinal metaplasia (SIM), is the precursor to esophageal adenocarcinoma (EAC). Despite published BE screening guidelines for at-risk individuals, uptake of endoscopic screening remains low. We present 18 months of real-world data on non-endoscopic BE screening using EsoGuard(R) (EG), the first commercially available U.S. molecular biomarker test for this purpose, performed on esophageal cell samples collected with the swallowable EsoCheck(R) (EC) balloon-capsule device. MethodsWe retrospectively analyzed EC performance and EG results in patients tested commercially from January 2023 to June 2024. A subset enrolled in a registry underwent follow-up endoscopy. Multivariable logistic regression was used to evaluate risk factors associated with (1) positive EG results, and (2) confirmed BE (SIM [&ge;]1 cm). ResultsAmong 11,991 tested patients, 11,355 (94.7%) had successful EC cell collection, averaging under 2 minutes with no serious adverse events. EG was positive in 16.6% of patients, with positivity increasing by age; age > 50 years was the strongest individual risk factor for predicting a positive EG result. Among 177 EG-positive registry patients who underwent endoscopy, 59 (33.3%) had SIM, of which 33 met American College of Gastroenterology criteria for BE and 26 had ultra-short SIM (<1 cm). Dysplasia was found in 3 patients: 1 HGD, 1 LGD, and 1 indefinite for dysplasia (IND). ConclusionsWe report here the largest real-world experience of EG and EC to date, demonstrating excellent safety, tolerability, and scalability. EG detects both guideline-recognized and ultra-short SIM, supporting its utility as a non-invasive BE screening tool.