Patent covers proprietary method using
methylation of the CCNA1 gene to help detect esophageal precancer
and cancer
NEW
YORK, Oct. 15, 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 it has received a Notice of Allowance from the
United States Patent and Trademark Office (USPTO) for a patent
application covering its proprietary method of using methylation of
the cyclin-A1 (CCNA1) gene to help detect esophageal precancer
and cancer, a key component of its EsoGuard® Esophageal
DNA Test.
"This patent strengthens the already robust intellectual
property portfolio underlying our groundbreaking technologies and
will provide strong protection for the CCNA1 methylation assay
method which is at the heart of the EsoGuard assay," said
Lishan Aklog, M.D., Lucid's Chairman
and Chief Executive Officer. "The allowance validates our strategy
of focusing on the laboratory methods of our assay—a strategy we
will continue to aggressively pursue for other components of the
assay."
EsoGuard utilizes next-generation sequencing (NGS) to assess DNA
methylation at 31 sites on two genes, vimentin (VIM) and cyclin-A1
(CCNA1). Such methylation has been shown to be strongly associated
with conditions along the spectrum from early esophageal precancer
(non-dysplastic Barrett's Esophagus or BE), to late precancer
(dysplastic BE), to cancer (esophageal adenocarcinoma).
Although VIM methylation had been previously associated with
gastrointestinal neoplasias, the association of CCNA1 methylation
with esophageal neoplasia is novel and appears to be more
specific.
The technology behind EsoGuard and the EsoCheck®
Esophageal Cell Collection Device was developed at Case Western Reserve University (CWRU) by faculty
members Sanford Markowitz, M.D.,
PhD, Amitabh Chak, M.D., and Joseph
Willis, M.D., with the support of research funds from the
National Institutes of Health (NIH) and elsewhere. Lucid holds the
exclusive worldwide license to commercialize this technology. The
successful transfer of the assay from the academic research
laboratory and its subsequent commercialization was the result of
close, ongoing collaboration between Lucid and CWRU.
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'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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SOURCE Lucid Diagnostics
