Featured Study
This multi-center, single-arm, case-control study was conducted by the Barrett's Esophagus Translational Research Network (BETRNet), evaluating clinical performance of the EsoGuard DNA methylation assay on cell samples collected non-endoscopically with EsoCheck, for detecting Barrett’s esophagus (BE) and esophageal adenocarcinoma (EAC). The EsoGuard assay was performed at the central commercial laboratory, Lucid Dx Labs, and showed high sensitivity (85%) and specificity (85%) for detecting disease. No cancers (EAC) were missed. These findings demonstrate this strategy to be practical for clinical implementation, and a viable office-based alternative to screening endoscopy for detection of BE/EAC.
Clinical Studies
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
First data snapshot from the multi-center, observational Clinical Utility of EsoGuard (CLUE) study which evaluates the provider decision impact of EsoGuard on samples collected with EsoCheck in the commercial setting. Initial data was collected from 275 subjects who were tested between February and July of 2017, among which provider decision impact data was available for 232. Findings demonstrated that physicians who order the test for patients in the commercial setting are consistently utilizing it as a triage to endoscopy for diagnosing Barrett’s Esophagus. There was nearly perfect concordance between EsoGuard results and physician decision on whether to refer the patient for additional endoscopic evaluation.
Clinical Utility of EsoGuard® as a Barrett’s Esophagus Triage Test for On-duty Firefighters
This is a retrospective analysis of prospectively collected data from two large health fairs for on-duty firefighters in San Antonio, TX, in January 2023. These where the first department-supported health fairs where Barrett’s esophagus screening with EsoGuard (on cells collected non-endoscopically with EsoCheck) was offered to on-duty firefighters at risk for BE/EAC. The data was analyzed for provider decision impact. Over two weekends (four days) 388 firefighters are tested, over 99% (365/388) successfully swallowed EsoCheck to provide a cell sample for analysis. There was a7.27% positivity rate, and 100% concordance between EsoGuard results and physician decision on whether to refer the patient for upper endoscopy. The test was demonstrated to be efficient in a high-volume, fast-paced setting, and well-tolerated, with strong physician decision impact.
Real World Experience and Clinical Utility of Esoguard® – Interim Data from the Lucid Registry
This manuscript presents an interim data snapshot from the multicenter, prospective, registry capturing data from patients undergoing testing with EsoGuard (on cells collected with EsoCheck) for detection of Barrett’s esophagus in the commercial setting. The snapshot evaluates 517 patients tested between April and August of 2023, among which data on EsoGuard results and provider decision impact is available for 437. Findings demonstrated that physicians who order the test for patients in the commercial setting are consistently utilizing it as a triage to endoscopy for diagnosing Barrett’s Esophagus. There was nearly perfect concordance between EsoGuard results and physician decision on whether to refer the patient for additional endoscopic evaluation.
Non-endoscopic screening for Barrett’s esophagus and Esophageal Adenocarcinoma in at-risk Veterans
This is a prospective, single-center, single-arm study evaluating the accuracy of EsoGuard on cells collected non-endoscopically with EsoCheck for the detection of Barrett’s esophagus (BE) and esophageal adenocarcinoma (EAC). Patients met criteria for upper endoscopic screening for BE based on current guidelines and were tested at an outpatient practice of a Veteran’s Affairs medical center. Results show BE/EAC prevalence of 12.9%, and EsoGuard had high sensitivity (92.9%) and strong negative predictive value (98.6%) for detection of disease. No cancers were missed. The excellent sensitivity and negative predictive value suggest this modality may serve as a powerful screening tool for BE and EAC.
Identifying DNA Methylation Biomarkers for Non-Endoscopic Detection of Barrett’s Esophagus
This NCI-funded multicenter case-control study is the pivotal study evaluating anon-endoscopic method for detecting Barrett’s Esophagus (BE) using a two-gene (VIM and CCNA1) DNA methylated biomarker on esophageal cells retrieved via a swallowable balloon-catheter device (EsoCheck). When combined, the two-biomarker panel was 90.3% sensitive and 91.7% specific for detection of BE-metaplasia in esophageal cell samples collected non-endoscopically with EsoCheck. Patient survey data supported high tolerability of the testing modality. These findings suggest that combining the balloon sampling device with molecular assays of CCNA1 plus VIM DNA methylation enables an efficient, well-tolerated, sensitive, and specific method of screening at-risk populations for BE.
Genetic Classifier to Differentiate Late-Stage Barrett’s Esophagus (HGD) and Esophageal Adenocarcinoma (EAC) from Early-Stage Disease (NDBE & LGD)
The study identifies genetic markers, particularly copy number alterations (CNA) and TP53 mutations, to differentiate early-stage Barrett's esophagus (BE) from late-stage BE and esophageal adenocarcinoma (EAC). Combining CNAs and TP53 mutations improves diagnostic accuracy, aiding in the early detection and treatment of BE progression. Presented at DDW 2024.
Analytical Validation of a DNA Methylation Biomarker Test for Diagnosis of BE and EAC from Samples Collected Using EsoCheck, a Non-endoscopic Esophageal Cell Collection Device
This report presents results of analytical validation studies for the EsoGuard assay, including analytical accuracy, analytical sensitivity, analytical specificity, linearity, lower limit of detection (LLOD), limit of blank (LOB), inter and intra-assay precision, reference interval and reportable range. Additionally, data for sample stability in preservative media during room temperature sample transportation as well as an interfering substance study are provided. Presented at AMP 2023.
Real World Data Using EsoCheck, a Non-endoscopic Esophageal Cell Collection Device for Early Detection of Barrett's Esophagus and Esophagus Adenocarcinoma
The study showcases the effectiveness of EsoCheck, a non-endoscopic device, in providing esophageal cell samples that can be used for a multitude of cytology and biomarker analyses, including the EsoGuard DNA test for detection of Barrett's Esophagus and Esophageal Adenocarcinoma. Patients had a 98% success rate in swallowing the device to provide a cell sample; the cell collection procedure was quick, performed without sedation, and well-tolerated. High DNA yields from collected cells support its ability to provide adequate samples for diagnostic analysis. Presented at DDW 2023.
Related Studies
AGA Clinical Practice Update on New Technology and Innovation for Surveillance and Screening in Barrett’s Esophagus: Expert Review
The American Gastroenterological Association Clinical Practice Update on Barrett's Esophagus (BE) recommends screening high-risk individuals using standard upper endoscopy or non-endoscopic cell-collection devices. Surveillance should use high-definition endoscopy and standardized biopsy protocols. Advanced imaging and risk stratification models are advised, with referrals to specialists for BE-related neoplasia. Regular proton pump inhibitor therapy and periodic surveillance endoscopy are essential.
Expanding beyond endoscopy: A review of non-invasive modalities in Barrett’s esophagus screening and surveillance
The article reviews non-invasive screening methods for Barrett’s esophagus (BE), a precursor to esophageal cancer. It highlights alternatives to traditional upper endoscopy, and how the methods offer less invasiveness, lower costs, and improved accessibility for mass screening and surveillance.
Diagnosis and Management of Barrett’s Esophagus: An Updated ACG Guideline
The updated American College of Gastroenterology guidelines for Barrett’s Esophagus (BE) focus on diagnosis, screening, and management. BE is linked to chronic gastroesophageal reflux disease and is a precursor to esophageal adenocarcinoma. Key updates include modification of the recommended screening population to no longer exclude women, suggestion of non-endoscopic alternatives to screening endoscopy, adjusted surveillance intervals, and recommendations for endoscopic eradication therapy for high-grade dysplasia. The guidelines emphasize patient-specific care based on current evidence and clinical judgment.
Novel Screening Alternatives for Barrett Esophagus
Barrett's esophagus (BE) is a condition that can lead to esophageal cancer. Traditional screening methods like endoscopy are costly and cumbersome. This article reviews newer, less invasive alternatives that show promise for wider, potentially more cost-effective screening.
Aberrant Vimentin Methylation Is Characteristic of Upper Gastrointestinal Pathologies
The study investigates aberrant DNA methylation of the Vimentin (VIM) gene in upper gastrointestinal cancers. It reveals that VIM methylation is highly prevalent in Barrett's esophagus, high-grade dysplasia, and esophageal adenocarcinoma, suggesting its potential as a biomarker for these conditions and for molecular cytology in esophageal cancer screening.
Carcinogenicity of Occupational Exposure as a Firefighter
Occupational exposure as a firefighter has been classified as carcinogenic to humans. Firefighters face various hazards, including smoke, chemicals, and physical stressors, contributing to these risks.
Mortality and Cancer Incidence in a Cohort of U.S. Firefighters from San Francisco, Chicago, and Philadelphia: An Update
The study updated the mortality data of 29,992 U.S. career firefighters from San Francisco, Chicago, and Philadelphia. The study found that mortality from esophageal cancer was elevated among firefighters, indicating a higher risk compared to the general population.
Mortality and cancer incidence in a pooled cohort of US firefighters from San Francisco, Chicago and Philadelphia (1950–2009)
The study analyzed mortality and cancer incidence among 29,993 US firefighters in San Francisco, Chicago, and Philadelphia from 1950 to 2009. Findings indicate higher rates of cancer, particularly digestive, respiratory, and esophageal cancers. The study underscores a link between firefighting and increased cancer risk due to occupational hazards.
Reflux Symptoms and Disorders and Pulmonary Disease in Former World Trade Center Rescue and Recovery Workers and Volunteers
Former World Trade Center rescue workers often suffer from gastroesophageal reflux disease (GERD), linked to inhalation injuries. This study found that GERD in these workers is associated with reduced lung function and more lower airway diseases, highlighting the need for comprehensive medical evaluation and treatment.
Registry-Based Case–Control Study of Cancer in California Firefighters
The study investigates cancer risks among California firefighters from 1988 to 2003. It reveals an increased risk of esophageal cancer among firefighters, likely due to exposure to carcinogens like nitrosamines during firefighting activities, highlighting the occupational hazards associated with firefighting.