Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2024 Nov 26;120(7):1511-1520.
doi: 10.14309/ajg.0000000000003238.

Use of a Two-Gene Methylated DNA Biomarker Assay and Nonendoscopic Balloon for Detection of Barrett Esophagus Among High-Risk Individuals in a Screening Population

Nicholas J Shaheen  1 , Mohamed O Othman  2 , Jawar Taunk  3 , Kenneth J Chang  4 , Sathya Jaganmohan  5 , Patrick S Yachimski  6 , John C Fang  7 , Joseph S Spataro  8 , Suman Verma  9 , Victoria T Lee  9 , Brian J deGuzman  9 , Lishan Aklog  9
Affiliations
Multicenter Study

Use of a Two-Gene Methylated DNA Biomarker Assay and Nonendoscopic Balloon for Detection of Barrett Esophagus Among High-Risk Individuals in a Screening Population

Nicholas J Shaheen et al. Am J Gastroenterol. .

Abstract

Introduction: Barrett 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 nonendoscopically with the EsoCheck (EC) device (EG/EC) for BE detection in the intended-use population meeting American College of Gastroenterology guideline criteria (chronic gastroesophageal reflux disease 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 United States and Spain participated. EC safety and usability were assessed as secondary endpoints.

Results: 180 male subjects aged >50 years with chronic gastroesophageal reflux disease met eligibility criteria, of which 163 (90.6%) had EGD and successful EC administration. Mean age was 60.5 years, 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% confidence interval [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.

Discussion: 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 nonendoscopic alternative in high-risk patients.

Keywords: Barrett esophagus; EsoCheck; EsoGuard; GERD; clinical validity; esophageal adenocarcinoma; nonendoscopic screening.

PubMed Disclaimer

References

    1. Thrift AP. Global burden and epidemiology of Barrett oesophagus and oesophageal cancer. Nat Rev Gastroenterol Hepatol 2021;18(6):432–43.
    1. Pohl H, Welch HG. The role of overdiagnosis and reclassification in the marked increase of esophageal adenocarcinoma incidence. J Natl Cancer Inst 2005;97(2):142–6.
    1. Devesa SS, Blot WJ, Fraumeni JF Jr. Changing patterns in the incidence of esophageal and gastric carcinoma in the United States. Cancer 1998;83(10):2049–53.
    1. Pera M, Cameron AJ, Trastek VF, et al. Increasing incidence of adenocarcinoma of the esophagus and esophagogastric junction. Gastroenterology 1993;104(2):510–3.
    1. Runge TM, Abrams JA, Shaheen NJ. Epidemiology of Barrett's esophagus and esophageal adenocarcinoma. Gastroenterol Clin North Am 2015;44(2):203–31.

Publication types

Supplementary concepts

Grants and funding