Clinical Utility Study of EsoGuard on Samples Collected with EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus - Interim Data of the First 275 Subjects

BackgroundBarretts Esophagus (BE) is the only known precursor for esophageal adenocarcinoma (EAC), a highly lethal malignancy which has had increasing incidence in Western populations over the last 40 years. Recommendations are for endoscopic screening of patients with multiple risk factors for BE, however most eligible patients are not undergoing such evaluation, or failing to be referred, leading to most patients with EAC being diagnosed without an existing BE diagnosis. EsoGuard(R) (EG) is a commercially available biomarker test for detection of BE, and when used to analyze cells collected non-endoscopically with EsoCheck(R) (EC), may serve as an easily accessible and well-tolerated diagnostic tool that has been recognized by the ACG and AGA as a reasonable alternative to screening endoscopy. The aim of this study was to evaluate the clinical utility of EG as a triage test for upper endoscopy in the diagnose BE in real world use. MethodsWe present the first data snapshot from a multi-center, observational trial evaluating the CLinical Utility of EsoGuard (CLUE) among physicians who have adopted the technology into their clinical practice. At the time of data snapshot, four centers had contributed to enrollment of 275 subjects between February 23, 2023, to July 28, 2023. Participating centers followed their own standard practices for determining whom to test with EG on cells collected with EC and subsequent management of the patient following results. Demographics, risk factors, test results, and subsequent management decisions were collected and analyzed. The clinical utility of the technology was evaluated based on the impact of the EG test results on the ordering physicians decision to refer or not refer a patient for further endoscopic evaluation. ResultsAmong 275 subjects contributing data for analysis, the average age was 61.9 years, and there was a similar distribution among males and females. Eighty-nine-point seven percent (89.7%) reported a history of chronic GERD, and 73.8% had GERD plus an additional 3 BE risk factors (i.e., ACG screening cohort). 232 subjects had EG results documented at the time of data analysis, among which 229 also had a physician decision on endoscopy referral. Total EG positivity rate was 29.3% (68/232) and 65.5% (152/232) were negative; the positive agreement between positive EG results and referral for endoscopy was 100%. The negative agreement between a negative EG result and non-referral for endoscopy was 99.3%. The overall concordance between EG result and endoscopy referral was 98.8%. This did not substantially differ between the ACG screening cohort compared to others. ConclusionsData from the first snapshot of the CLUE study demonstrates physicians ordering EC/EG in the commercial setting are reliably utilizing EG results as a triage tool to guide referrals for endoscopic evaluation of BE. Physicians always refer EG(+) individual for additional endoscopic evaluation, whereas EG(-) subjects are consistently being spared an invasive test.