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Lucid Diagnostics Announces Positive Data from its ESOGUARD BE-1 Prospective, International, Multicenter Clinical Validation Study of EsoGuard® Esophageal Precancer Testing in a Screening Population
Prospective screening study demonstrates excellent EsoGuard sensitivity of 87.5% and negative predictive value (NPV) of 98.6% Previously announced positive
About this update from Lucid Diagnostics Inc.
[{"type":"text","content":"Prospective screening study demonstrates excellent EsoGuard sensitivity of 87.5% and negative predictive value (NPV) of 98.6% \nPreviously announced positive data from a separate prospective VA screening study also accepted for peer-reviewed publication\nStudies further strengthen EsoGuard's clinical validity data in support of upcoming Medicare LCD pre-submission meeting and ongoing commercial payor engagements\nNEW YORK, July 2, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) (\"Lucid\" or the \"Company\") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced positive data from its ESOGUARD BE-1 prospective, international, multicenter, single-arm study conducted to clinically validate performance of the EsoGuard® Esophageal DNA test on samples collected with the EsoCheck® Esophageal Cell Collection Device for detection of esophageal precancer (Barrett's Esophagus or BE) and esophageal adenocarcinoma (EAC) in a screening population. This is the second clinical validation study in a screening population following previously announced positive data from the Cleveland VA screening study, which was recently accepted for peer-reviewed publication.\n\n \n \n \n \n \n \n\n \nThe ESOGUARD BE-1 study was led by Nicholas J. Shaheen, M.D., M.P.H., Professor of Medicine and Epidemiology at the University of North Carolina School of Medicine, a leading esophageal precancer expert and lead author of the American College of Gastroenterology (ACG) guidelines on esophageal precancer screening. Study sites included leading academic medical centers, such as Baylor College of Medicine, University of California-Irvine, Vanderbilt University, and University of Utah, as well as other notable U.S. and European centers. The manuscript entitled Use of the EsoGuard® Molecular Biomarker Test in Non-Endoscopic Detection of Barrett's Esophagus among High-Risk Individuals in a Screening Population demonstrated high sensitivity and negative predictive value (NPV) compared to upper gastrointestinal endoscopy and is currently available on the leading health sciences preprint server, MedRxiv, pending peer review and publication.\nThe manuscript for the Cleveland VA screening study, entitled Non-endoscopic screening for Barrett's esophagus and Esophageal Adenocarc...