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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/lucid-diagnostics-esoguard-be-1-prospective-multicenter-clinical-validation-study-of-esoguard-esophageal-precancer-testing-accepted-for-peer-reviewed-publication-302298293.html
SOURCE Lucid Diagnostics
