Use of the EsoGuard® Molecular Biomarker Test in Non-Endoscopic Detection of Barrett's Esophagus among High-Risk Individuals in a Screening Population

Abstract

Background and Aims: Barrett's Esophagus (BE) is the precursor to esophageal adenocarcinoma (EAC). We aimed to assess performance, safety, and tolerability of the EsoGuard (EG) assay on samples collected non-endoscopically with the EsoCheck (EC) device (EG/EC) for BE detection in the intended-use population, meeting American College of Gastroenterology (ACG) guideline criteria (chronic gastroesophageal reflux disease (GERD) and 3+ additional risk factors). Methods: We performed a prospective, multicenter study (NCT04293458) to assess EG performance (primary endpoint) on cells collected with EC, for detection of BE and EAC using esophagogastroduodenoscopy (EGD) and biopsies as the comparator. Twenty-four sites across the U.S. and Spain participated. EC safety and usability were assessed as secondary endpoints. Results: 180 male subjects aged >50 years with chronic GERD met eligibility criteria, of which 163 (90.6%) had EGD and successful EC administration. Mean age was 60.5yrs, 34.4% were obese, 56.7% had tobacco history, and 3.9% had a 1st degree relative with BE or EAC. Of 122 samples analyzed, 93 contributed to the primary endpoint analysis. About 9% of subjects in the Primary Analysis Population had BE on EGD, none with dysplasia. Sensitivity of EG for BE was 87.5% (95% CI 47.4-99.7), specificity was 81.2% (95% CI 71.2-88.8), positive predictive value was 30.4% (95% CI 13.2-52.9), and negative predictive value was 98.6% (95% CI 92.3-99.96). Mild esophageal abrasions were observed in 1.5%; no serious adverse events were reported. Conclusions: EG/EC appears effective for BE screening. This approach provides a safe, accurate, and well-tolerated non-endoscopic alternative in high-risk patients.