Use of a Two-gene Methylated DNA Biomarker Assay and Non-Endoscopic Balloon for Detection of Barrett’s Esophagus among High-Risk Individuals in a Screening Population
Nicholas J. Shaheen, Mohamed O. Othman, Jawar Taunk, Kenneth J. Chang, Sathya Jaganmohan, Patrick S. Yachimski, John C. Fang, Joseph S. Spataro, Suman Verma, Victoria T. Lee, Brian J. deGuzman, Lishan AklogBackground 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. Eight subjects (8.6%) 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:
This study in the intended-use population suggests that EG/EC is promising for BE screening. While future work is necessary to define its performance characteristics with more precision, this approach may provide a safe, accurate, and well-tolerated non-endoscopic alternative in high-risk patients.