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

Background: Barrett’s esophagus (BE), defined by specialized intestinal metaplasia (SIM), is the recognized precursor to esophageal adenocarcinoma (EAC). Despite established screening guidelines for high-risk populations, uptake of endoscopic screening remains low. We report the results of early commercial use of a non-endoscopic BE screening strategy, EsoGuard® (EG), a molecular biomarker assay performed on esophageal cell samples collected via a companion swallowable balloon capsule device (EsoCheck®, EC). Methods: We retrospectively analyzed the feasibility and tolerability of EG/EC as a non-endoscopic approach to BE evaluation in patients tested from January 2023 through June 2024. Multivariable logistic regression was used to evaluate risk factors associated with positive EG results. Results: Among 11,991 patients tested, 11,355 (94.7%) had successful cell collection with the EC device, with procedures averaging less than 2 minutes and no device-related adverse events reported. Over 95% of surveyed patients would recommend the test to others. Overall, 93.1% (10,566/11,355) of collected samples had binary EG results, among which 17.8% had positive assay results suggesting the presence of BE. Positivity rates increased with age, with age > 50 years as the strongest individual predictor of a positive EG result. Conclusions: These data represent the largest real-world experience with EG and EC to date, demonstrating high tolerability and no reported device-related adverse events. The findings support the feasibility of large-scale implementation and suggest that EG/EC use may improve access to guideline-recommended BE screening across diverse healthcare settings.