{"doi":"10.1101/2024.06.24.24309401","title":"Use of the EsoGuard\n                  <sup>®</sup>\n                  Molecular Biomarker Test in Non-Endoscopic Detection of Barrett’s Esophagus among High-Risk Individuals in a Screening Population","abstract":"<jats:title>Abstract</jats:title>\n                <jats:sec>\n                  <jats:title>Background and Aims</jats:title>\n                  <jats:p>Barrett’s Esophagus (BE) is the precursor to esophageal adenocarcinoma (EAC). We aimed to assess performance, safety, and tolerability of the EsoGuard (EG) assay on samples collected non-endoscopically with the EsoCheck (EC) device (EG/EC) for BE detection in the intended-use population, meeting American College of Gastroenterology (ACG) guideline criteria (chronic gastroesophageal reflux disease (GERD) and 3+ additional risk factors).</jats:p>\n                </jats:sec>\n                <jats:sec>\n                  <jats:title>Methods</jats:title>\n                  <jats:p>\n                    We performed a prospective, multicenter study (\n                    <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04293458\">NCT04293458</jats:ext-link>\n                    ) to assess EG performance (primary endpoint) on cells collected with EC, for detection of BE and EAC using esophagogastroduodenoscopy (EGD) and biopsies as the comparator. Twenty-four sites across the U.S. and Spain participated. EC safety and usability were assessed as secondary endpoints.\n                  </jats:p>\n                </jats:sec>\n                <jats:sec>\n                  <jats:title>Results</jats:title>\n                  <jats:p>\n                    180 male subjects aged &gt;50 years with chronic GERD met eligibility criteria, of which 163 (90.6%) had EGD and successful EC administration. Mean age was 60.5yrs, 34.4% were obese, 56.7% had tobacco history, and 3.9% had a 1\n                    <jats:sup>st</jats:sup>\n                    degree relative with BE or EAC. Of 122 samples analyzed, 93 contributed to the primary endpoint analysis. About 9% of subjects in the Primary Analysis Population had BE on EGD, none with dysplasia. Sensitivity of EG for BE was 87.5% (95% CI 47.4-99.7), specificity was 81.2% (95% CI 71.2-88.8), positive predictive value was 30.4% (95% CI 13.2-52.9), and negative predictive value was 98.6% (95% CI 92.3-99.96). Mild esophageal abrasions were observed in 1.5%; no serious adverse events were reported.\n                  </jats:p>\n                </jats:sec>\n                <jats:sec>\n                  <jats:title>Conclusions</jats:title>\n                  <jats:p>EG/EC appears effective for BE screening. This approach provides a safe, accurate, and well-tolerated non-endoscopic alternative in high-risk patients.</jats:p>\n                </jats:sec>","journal":null,"year":null,"id":647531,"datarank":0.18379749179944077,"base_score":1.0986122886681096,"endowment":1.0986122886681096,"self_citation_contribution":0.16479184330021646,"citation_network_contribution":0.019005648499224304,"self_endowment_contribution":0.16479184330021646,"citer_contribution":0.019005648499224304,"corpus_percentile":null,"corpus_rank":null,"citation_count":2,"citer_count":1,"citers_with_citation_signal":1,"citers_with_endowment":1,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":871055,"name":"Mohamed O. Othman","orcid":"0000-0002-5888-4334","position":1,"is_corresponding":false},{"id":1670438,"name":"Jawar Taunk","orcid":null,"position":2,"is_corresponding":false},{"id":479751,"name":"Kenneth J. Chang","orcid":"0000-0001-9897-277X","position":3,"is_corresponding":false},{"id":1670441,"name":"Sathya Jaganmohan","orcid":"0009-0004-4683-4710","position":4,"is_corresponding":false},{"id":1670443,"name":"Patrick S. Yachimski","orcid":null,"position":5,"is_corresponding":false},{"id":1400018,"name":"John C. Fang","orcid":"0000-0003-3274-3979","position":6,"is_corresponding":false},{"id":1670445,"name":"Joseph S. Spataro","orcid":"0000-0001-8015-3821","position":7,"is_corresponding":false},{"id":622178,"name":"Suman Verma","orcid":null,"position":8,"is_corresponding":false},{"id":1493025,"name":"Victoria T. Lee","orcid":"0009-0005-7128-2919","position":9,"is_corresponding":false},{"id":1670446,"name":"Brian J. deGuzman","orcid":null,"position":10,"is_corresponding":false},{"id":1166504,"name":"Lishan Aklog","orcid":"0009-0007-2476-5533","position":11,"is_corresponding":false},{"id":365133,"name":"Nicholas J. Shaheen","orcid":"0000-0001-6602-5647","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Use of the EsoGuard\n                  <sup>®</sup>\n                  Molecular Biomarker Test in Non-Endoscopic Detection of Barrett’s Esophagus among High-Risk Individuals in a Screening Population","abstract":"<jats:title>Abstract</jats:title>\n                <jats:sec>\n                  <jats:title>Background and Aims</jats:title>\n                  <jats:p>Barrett’s Esophagus (BE) is the precursor to esophageal adenocarcinoma (EAC). We aimed to assess performance, safety, and tolerability of the EsoGuard (EG) assay on samples collected non-endoscopically with the EsoCheck (EC) device (EG/EC) for BE detection in the intended-use population, meeting American College of Gastroenterology (ACG) guideline criteria (chronic gastroesophageal reflux disease (GERD) and 3+ additional risk factors).</jats:p>\n                </jats:sec>\n                <jats:sec>\n                  <jats:title>Methods</jats:title>\n                  <jats:p>\n                    We performed a prospective, multicenter study (\n                    <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04293458\">NCT04293458</jats:ext-link>\n                    ) to assess EG performance (primary endpoint) on cells collected with EC, for detection of BE and EAC using esophagogastroduodenoscopy (EGD) and biopsies as the comparator. Twenty-four sites across the U.S. and Spain participated. EC safety and usability were assessed as secondary endpoints.\n                  </jats:p>\n                </jats:sec>\n                <jats:sec>\n                  <jats:title>Results</jats:title>\n                  <jats:p>\n                    180 male subjects aged &gt;50 years with chronic GERD met eligibility criteria, of which 163 (90.6%) had EGD and successful EC administration. Mean age was 60.5yrs, 34.4% were obese, 56.7% had tobacco history, and 3.9% had a 1\n                    <jats:sup>st</jats:sup>\n                    degree relative with BE or EAC. Of 122 samples analyzed, 93 contributed to the primary endpoint analysis. About 9% of subjects in the Primary Analysis Population had BE on EGD, none with dysplasia. Sensitivity of EG for BE was 87.5% (95% CI 47.4-99.7), specificity was 81.2% (95% CI 71.2-88.8), positive predictive value was 30.4% (95% CI 13.2-52.9), and negative predictive value was 98.6% (95% CI 92.3-99.96). Mild esophageal abrasions were observed in 1.5%; no serious adverse events were reported.\n                  </jats:p>\n                </jats:sec>\n                <jats:sec>\n                  <jats:title>Conclusions</jats:title>\n                  <jats:p>EG/EC appears effective for BE screening. This approach provides a safe, accurate, and well-tolerated non-endoscopic alternative in high-risk patients.</jats:p>\n                </jats:sec>","is_dataset_classified":null,"base_score":0.0,"endowment":0.0,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"19162232","pmcid":null,"openalex_id":null,"authors":[],"funders":[],"total_grants":0,"fwci":null,"citation_percentile":null,"influential_citations":0,"citation_trend":[],"oa_status":"green","license":null,"oa_locations":[{"url":"https://www.medrxiv.org/content/medrxiv/early/2024/06/26/2024.06.24.24309401.full.pdf","host_type":"repository"},{"url":"https://syndication.highwire.org/content/doi/10.1101/2024.06.24.24309401","host_type":"publisher"}],"fields_of_study":[],"mesh_terms":[],"keywords":[],"sdg_mappings":[],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-10T00:49:15.799226Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}