Study demonstrates excellent analytical
accuracy, repeatability, and reproducibility of the assay
NEW
YORK, Aug. 20, 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 the peer-reviewed publication of an analytical
validation study of its EsoGuard® Esophageal DNA
test for the diagnosis of esophageal precancer (Barrett's Esophagus
or BE) and esophageal adenocarcinoma (EAC) on samples collected
non-endoscopically using Lucid's EsoCheck® Esophageal
Cell Collection Device. The manuscript, entitled Analytical
Validation of a DNA Methylation Biomarker Test for the Diagnosis of
Barrett's Esophagus and Esophageal Adenocarcinoma from Samples
Collected Using EsoCheck®, a Non-Endoscopic Esophageal
Cell Collection Device, has been published in the peer-reviewed
journal Diagnostics, and is currently available via open
access online.
"This analytical validation study strongly complements
EsoGuard's extensive peer-reviewed, published clinical validity and
clinical utility evidence base," said Suman Verma, M.D., PhD, Lucid's Chief Scientific
Officer. "The results demonstrate very robust analytical
performance of the EsoGuard assay performed in our CLIA-certified,
CAP-accredited, NY State-approved commercial laboratory."
The publication details comprehensive studies demonstrating
excellent analytical performance of the EsoGuard assay on samples
collected with EsoCheck, including 89% analytical sensitivity, 100%
analytical specificity, 96% analytical accuracy, and 100% inter-
and intra-assay precision. EsoGuard utilizes next-generation
sequencing (NGS) to detect DNA methylation at 31 sites on two
genes, vimentin (VIM) and cyclin A1 (CCNA1), which have been shown
to be associated with conditions along the BE-EAC spectrum.
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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SOURCE Lucid Diagnostics
