Real-World Clinical Utility of a Methylated DNA Biomarker Assay on Samples Collected with a Swallowable Capsule-Balloon for Detection of Barrett's Esophagus (BE)

Background: Barrett's Esophagus (BE) is the only known precursor for esophageal adenocarcinoma (EAC). Patients with multiple risk factors for BE/EAC are recommended for screening; however, few eligible patients undergo evaluation by endoscopy. EsoGuard^® (EG) is a commercially available biomarker assay used to analyze esophageal cells collected non-endoscopically with EsoCheck^® (EC) for the qualitative detection of BE/EAC. This study evaluates the real-world clinical utility of EG on cells collected with EC in patients defined by U.S. gastroenterology societies to be at-risk for BE and EAC. Methods: This multi-center, observational CLinical Utility of EsoGuard (CLUE) study enrolled screening-eligible patients as defined by the American College of Gastroenterology (ACG) and the American Gastroenterological Association (AGA). Clinical utility was evaluated by the provider decision impact of EG and additionally by assessing patient compliance outcomes with recommended follow-up testing. Results: There were 551 patients enrolled, with a mean age of 62.0 ± 12.4 years and 56.1% (309/551) meeting ACG guideline criteria for BE screening. EC cell collection was successful in 97.1% (535/551), among which the EG positivity rate was 27.3% (n = 146). The provider decision impact was high, with 100% of EG-positive patients being referred for esophagogastroduodenoscopy (EGD), while 98% of EG negative patients were not referred. Among the EG-positive patients, the overall compliance with follow-up EGD was 85.4%. Conclusions: Combining EC non-endoscopic esophageal cell collection with the EG biomarker assay is effective in guiding provider decision-making for the detection of BE and EAC. Patients with positive EG results demonstrate high compliance with recommended follow-up EGD.