Real World Experience and Clinical Utility of Esoguard® - Interim Data from the Lucid Registry

Abstract

Background: Barrett’s Esophagus (BE) is the only known precursor to esophageal adenocarcinoma (EAC), but historically, screening rates have been low, likely influenced by limitations of upper endoscopy (UE) as the traditional screening modality. EsoGuard® (EG) is a DNA biomarker assay, and EsoCheck® (EC) a noninvasive, swallowable capsule device designed to collect cells from a targeted region of the esophagus. EG and EC in combination offers a well-tolerated, in-office triage test to facilitate BE detection in patients with multiple risk factors. The Lucid Registry captures real-world data from commercial use of EC with EG; we present an interim review of clinical utility data from the first 517 subjects. Methods: Multicenter, prospective, registry capturing data from patients undergoing EC/EG in the commercial setting. This snapshot includes subjects enrolled from registry initiation (April 14, 2023) through August 16, 2023. The primary measure of clinical utility was provider decision impact, namely agreement between EG results and physician decision on whether to refer for subsequent UE. The relationship between BE/EAC risk factors and EG positivity rates was also assessed. Results: Average age was 47.9±14.3 years, 47.2% had history of gastroesophageal reflux disease (GERD), and 63.8% had ≥3 traditional BE/EAC risk factors. 58.8% of subjects were firefighters; when firefighting was treated as an additional BE/EAC risk factor, 81.2% of the study population had ≥3. EG positivity was 14.1%. 437 subjects were followed to the clinical utility endpoint: agreement between EG (+) results and referral for UE was 100%; agreement between EG (-) results and non-referral for UE was 99.4%; concordance between EG results and UE referral was 97.9%. Conclusions: Experience from the Lucid Registry demonstrates that physicians who have adopted EC/EG in the commercial setting are reliably utilizing EG as a triage test to inform decisions on which patients to refer for further endoscopic evaluation of BE.