Clinical Utility of EsoGuard® on Samples Collected with EsoCheck® as a Triage to Endoscopy for Identification of Barrett’s Esophagus – Interim Data from the CLUE Study

Author(s): Dan Lister, Andy Fine, Shail Maheshwari, Paul S. Bradley, Victoria T. Lee, Brian J. deGuzman, Suman Verma, Lishan Aklog

Background: Barrett’s Esophagus (BE) is the only known precursor for esophageal adenocarcinoma (EAC). Recommendations are to screen patients with multiple risk factors; however, few eligible patients undergo evaluation. EsoGuard® (EG) is a commercially available biomarker test, which when used to analyze esophageal cells collected non-endoscopically with EsoCheck® (EC), may serve as an easily accessible and well-tolerated qualitative diagnostic tool. This study evaluates real-world clinical utility of EG as a triage to upper endoscopy (UE) for diagnosis of BE.

Methods: First data snapshot from the multi-center, observational Clinical Utility of EsoGuard (CLUE) trial. 275 subjects enrolled between February 23 - July 28, 2023. Patient demographics, risk factors, EG results, and next steps in management were collected. Clinical Utility was evaluated based on the impact of EG test results on physician’s decision to refer/not refer patients for UE evaluation

Results: Average age was 61.9 years, with similar distribution of males and females. 89.7% had chronic gastroesophageal reflux disease (GERD), and 73.8% had GERD plus three additional BE risk factors. EG positivity was 29.3% (68/232); 229 subjects had both EG results and a physician decision on UE referral. Positive agreement between EG(+) results and referral for UE was 100%; negative agreement between EG(-) results and non-referral was 99.3%. Overall concordance between EG results and UE referral was 98.8%.

Conclusions: The first snapshot of the CLUE study demonstrates physicians ordering EG/EC in the commercial setting are reliably utilizing it as a triage to UE for evaluation of patients at high risk of BE/EAC.