Study supports expanded indication and market
opportunity for EsoGuard esophageal precancer testing
NEW
YORK, April 24, 2025 /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 positive data from a National Cancer Institute
(NCI)-sponsored study demonstrating that its EsoGuard®
Esophageal DNA Test can effectively detect esophageal precancer
(Barrett's Esophagus or BE) among at-risk patients without
symptoms of chronic gastroesophageal reflux disease (GERD), such as
heartburn. These results support EsoGuard esophageal precancer
testing in an expanded target population, consistent with existing
American Gastroenterological Association (AGA) guidelines and has
the potential to substantially increase the market opportunity.
Positive results from this study led to a larger ongoing five-year
multicenter clinical study evaluating EsoGuard in asymptomatic
patients supported by an $8
million National Institutes of Health (NIH) R01
grant.
The study was conducted by investigators at Case Western Reserve University (CWRU) and
University Hospitals (UH) and enrolled patients without GERD
symptoms who otherwise met AGA recommendations for BE screening.
EsoGuard demonstrated excellent negative predictive value (NPV) of
100% for detecting esophageal precancer, consistent with its
unprecedented precancer detection reported across multiple
peer-reviewed clinical validity studies in patients with
symptomatic GERD. The study also showed a BE prevalence of 8.4%, a
rate comparable to the established prevalence in patients with
symptomatic GERD. The manuscript, entitled Nonendoscopic
Detection of Barrett's Esophagus in Patients Without GERD
Symptoms, is currently available on the leading health sciences
preprint server, MedRxiv, and has been submitted for peer-reviewed
publication.
"This study represents yet another piece of evidence that
EsoGuard is highly effective at detecting esophageal precancer to
prevent cancer," said Lishan Aklog,
M.D., Lucid's Chairman and Chief Executive Officer. "The meaningful
BE prevalence reported in this study establishes the asymptomatic
population as a viable target for BE screening. If these promising
results are replicated in the ongoing multicenter NIH-sponsored
study, the approximately $60 billion
market opportunity for EsoGuard esophageal precancer testing could
increase by as much as 70 percent."
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 about Lucid, 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 Diagnostics'
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 Diagnostics'
common stock; general economic and market conditions; the
uncertainties inherent in research and development, including the
cost and time required to advance Lucid Diagnostics' products to
regulatory submission; whether regulatory authorities will be
satisfied with the design of and results from Lucid Diagnostics'
clinical and preclinical studies; whether and when Lucid
Diagnostics' products are cleared by regulatory authorities; market
acceptance of Lucid Diagnostics' products once cleared and
commercialized; Lucid Diagnostics' ability to raise additional
funding as needed; and other competitive developments. These
factors are difficult or impossible to predict accurately and many
of them are beyond Lucid Diagnostics' 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
Diagnostics' future operations, see Part I, Item 1A, "Risk
Factors," in Lucid Diagnostics' 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 Diagnostics 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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