Real World Experience and Clinical Utility of EsoGuard(R) - Interim Data from the Lucid Registry

BackgroundBarretts Esophagus (BE) is the only known precursor to esophageal adenocarcinoma (EAC), and guidelines exist for screening, surveillance, and treatment. However, historically most high-risk individuals have not been reliably screened, likely due to a combination of factors associated with patient/physician awareness and use of upper endoscopy (UE) as the traditional screening test. EsoGuard(R) (EG) is a DNA biomarker assay, and EsoCheck(R) (EC) is a non-invasive, swallowable capsule device designed to collect cells from a targeted region of the esophagus. EG and EC in combination offers a well-tolerated, accessible, in-office triage test to improve detection of BE in patients with multiple risk factors. The Lucid Registry captures real-world data from the commercial use of EC with EG, and we present an interim review of clinical utility data from the first 517 enrolled subjects. MethodsMulticenter, prospective, registry designed to capture data from patients undergoing EC cell collection and EG testing in the commercial setting. Data collection consists of demographics, risk factors, test results, provider management, and early clinical outcomes (through a maximum of four months post-EG). This data snapshot includes subjects enrolled from the start of the registry (April 14, 2023), through August 16, 2023. The primary assessment of clinical utility was agreement between EG assay results and physicians decision on whether to refer the patient for subsequent UE. The relationship between BE/EAC risk factors and EG positivity rates was assessed. ResultsAmong 517 subjects enrolled, average age was 47.9{+/-}14.3 years, 47.2% had history of gastroesophageal reflux disease (GERD), and 63.8% had a minimum of 3 established BE risk factors (i.e., met American Gastroenterological Association (AGA) criteria for screening). 58.8% of subjects were firefighters; when firefighting i.e., occupational exposure to smoke and carcinogens is treated as an additional BE/EAC risk factor (+) those of the AGA, 81.2% of the study population had [≥]3 risks, making up the "AGA(+)" cohort. EG positivity was 14.1%. 437 subjects contributed data for the clinical utility endpoint: agreement between positive EG results and subsequent referral for UE was 100%; agreement between negative EG results and non-referral for UE was 99.4%; concordance between EG results and UE referral decisions was 97.9%. These findings were comparable between the AGA and AGA(+) cohorts. ConclusionsExperience 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 decision making on which patients to refer for further endoscopic evaluation of BE.