Publication, which once again demonstrates strong EsoGuard performance in a screening population, completes Lucid's clinical evidence package for submission to formally seek Medicare coverage
NEW YORK, Nov. 7, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced that the manuscript for its multicenter ESOGUARD BE-1 study has been accepted for publication in The American Journal of Gastroenterology, the official journal of the American College of Gastroenterology (ACG). This is the fourth publication presenting clinical validation data for Lucid's EsoGuard® Esophageal DNA Test, and the second to demonstrate its strong performance in an intended-use screening population. Consistent with previous studies, EsoGuard showed high sensitivity and negative predictive value in detecting esophageal precancer (Barrett's Esophagus or BE).
"The publication of the ESOGUARD BE-1 study, which once again demonstrated unprecedented EsoGuard performance, is a major milestone for Lucid," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "With this fourth clinical validation study accepted for peer-reviewed publication, we believe we now have a complete clinical evidence package to submit our data to the MolDX program and formally seek Medicare coverage. We are deeply grateful to Dr. Shaheen and the other investigators, across two continents, for their hard work and commitment to esophageal cancer prevention."
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, follows manuscripts from two other EsoGuard clinical validation studies, the Cleveland VA and BETRNET studies, both of which were published in the American Journal of Gastroenterology earlier this year.
The principal investigator of the ESOGUARD BE-1 study and lead author of the manuscript was leading esophageal precancer expert Nicholas J. Shaheen, M.D., M.P.H., the Bozymski-Heizer Distinguished Professor of Medicine and Epidemiology at the University of North Carolina School of Medicine, and lead author of the 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 prospective, multicenter study presented data from a cohort of patients who met ACG guideline criteria for esophageal precancer screening and underwent non-endoscopic EsoGuard testing followed by traditional upper endoscopy. EsoGuard sensitivity and negative predictive value for detecting BE were approximately 88% and 99%, respectively. Specificity and positive predictive value were approximately 81% and 30%, respectively. No serious adverse events were reported. The results once again demonstrate EsoGuard's reliability as an esophageal precancer screening tool, offering a safe and more accessible alternative to traditional endoscopic methods. The study authors concluded that "EsoGuard DNA biomarker testing was well-tolerated, convenient, safe, and efficient...with a PPV and a NPV that can appropriately guide clinical decision-making."
About Lucid Diagnostics
Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device, represent the first and only commercially available tools designed with the goal of preventing cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients.
For more information, please visit www.luciddx.com and for more information about its parent company PAVmed, please visit www.pavmed.com.
Forward-Looking Statements
This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid's management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid's common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid's clinical and preclinical studies; whether and when Lucid's products are cleared by regulatory authorities; market acceptance of Lucid's products once cleared and commercialized; Lucid's ability to raise additional funding as needed; and other competitive developments. In addition, Lucid continues to monitor the COVID-19 pandemic and the pandemic's impact on Lucid's businesses. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid's control. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect Lucid's future operations, see Part I, Item 1A, "Risk Factors," in Lucid's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics after its most recent Annual Report. Lucid disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.
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