PreprintArticleVersion 1This version is not peer-reviewed
Real-world Clinical Utility of a Methylated DNA Biomarker Assay on Samples Collected with a Swallowable Capsule-balloon for Detection of Barrett’s Esophagus (BE)
Version 1
: Received: 1 November 2024 / Approved: 5 November 2024 / Online: 5 November 2024 (09:47:11 CET)
How to cite:
Lister, D.; Fine, A.; Maheshwari, S.; Bradley, P. S.; Lister, B.; Lee, V. T.; DeGuzman, B. J.; Verma, S.; Aklog, L. Real-world Clinical Utility of a Methylated DNA Biomarker Assay on Samples Collected with a Swallowable Capsule-balloon for Detection of Barrett’s Esophagus (BE). Preprints2024, 2024110272. https://doi.org/10.20944/preprints202411.0272.v1
Lister, D.; Fine, A.; Maheshwari, S.; Bradley, P. S.; Lister, B.; Lee, V. T.; DeGuzman, B. J.; Verma, S.; Aklog, L. Real-world Clinical Utility of a Methylated DNA Biomarker Assay on Samples Collected with a Swallowable Capsule-balloon for Detection of Barrett’s Esophagus (BE). Preprints 2024, 2024110272. https://doi.org/10.20944/preprints202411.0272.v1
Lister, D.; Fine, A.; Maheshwari, S.; Bradley, P. S.; Lister, B.; Lee, V. T.; DeGuzman, B. J.; Verma, S.; Aklog, L. Real-world Clinical Utility of a Methylated DNA Biomarker Assay on Samples Collected with a Swallowable Capsule-balloon for Detection of Barrett’s Esophagus (BE). Preprints2024, 2024110272. https://doi.org/10.20944/preprints202411.0272.v1
APA Style
Lister, D., Fine, A., Maheshwari, S., Bradley, P. S., Lister, B., Lee, V. T., DeGuzman, B. J., Verma, S., & Aklog, L. (2024). Real-world Clinical Utility of a Methylated DNA Biomarker Assay on Samples Collected with a Swallowable Capsule-balloon for Detection of Barrett’s Esophagus (BE). Preprints. https://doi.org/10.20944/preprints202411.0272.v1
Chicago/Turabian Style
Lister, D., Suman Verma and Lishan Aklog. 2024 "Real-world Clinical Utility of a Methylated DNA Biomarker Assay on Samples Collected with a Swallowable Capsule-balloon for Detection of Barrett’s Esophagus (BE)" Preprints. https://doi.org/10.20944/preprints202411.0272.v1
Abstract
Background: Barrett’s Esophagus (BE) is the only known precursor for esophageal adenocarcinoma (EAC). Patients with multiple risk factors for BE/EAC are recommended for screening, however few eligible patients undergo evaluation by endoscopy. EsoGuard® (EG) is a commercially available biomarker assay used to analyze esophageal cells collected non-endoscopically with EsoCheck® (EC), for qualitative detection of BE/EAC. This study evaluates real-world clinical utility of EG on cells collected with EC in patients defined by U.S. gastroenterology societies to be at-risk for BE and EAC. Methods: This multi-center, observational CLinical Utility of EsoGuard (CLUE) study enrolled screening-eligible patients as defined by the American College of Gastroenterology (ACG) and the American Gastroenterological Association (AGA). Clinical utility was evaluated by the provider decision impact of EG, and additionally by assessing patient compliance outcomes with recommended follow-up testing. Results: 551 patients were enrolled, with a mean age of 62.0 ± 12.4 years and 56.1% (309/551) meeting ACG guideline criteria for BE screening. EC cell collection was successful in 97.1% (535/551), among which EG positivity rate was 27.3% (n = 146). The provider decision impact was high with 100% of EG positive patients being referred for esophagogastroduodenoscopy (EGD), while 98% of EG negative patients were not referred. Among EG positive patients, the overall compliance with follow-up EGD was 85.4%. Conclusions: Combining EC non-endoscopic esophageal cell collection with the EG biomarker assay is effective in guiding provider decision-making for detection of BE and EAC. Patients with positive EG results demonstrate high compliance with recommended follow-up EGD.
Medicine and Pharmacology, Gastroenterology and Hepatology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
