NEW
YORK, Nov. 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 that it has submitted its complete clinical
evidence package for its EsoGuard® Esophageal DNA
Test in support of a Request for Reconsideration of Local
Coverage Determination (LCD) L39256 "MolDX: Molecular Testing
for Detection of Upper Gastrointestinal Metaplasia,
Dysplasia, and Neoplasia" to Molecular Diagnostics Program
(MolDX), administered by Palmetto GBA, a Medicare Administrative
Contractor (MAC) for the Centers for Medicare & Medicaid
Services (CMS), to seek coverage for EsoGuard.
"This submission is the culmination of many years of persistent
hard work by our team and our many clinical research partners, and
represents perhaps the most important milestone in Lucid's
history," said Lishan Aklog, M.D.,
Lucid's Chairman and Chief Executive Officer. "We believe the data
in this package strongly supports EsoGuard's clinical validity,
utility, and analytical accuracy, aligning with the MolDX criteria
for coverage as outlined in the LCD. The clinical validity data, in
particular, demonstrates EsoGuard's unprecedented precancer
detection performance across all studies. We look forward to the
opportunity to expand access to EsoGuard precancer testing to all
at-risk Medicare beneficiaries."
The EsoGuard clinical evidence package includes six new
peer-reviewed publications: three clinical validation studies (two
in the intended use population, one case control), two clinical
utility studies, and one analytical validation study. The current
LCD provides clear coverage criteria consistent with the American
College of Gastroenterology (ACG) guidelines for esophageal
precancer testing. The package was submitted as part of a request
for reconsideration of the non-coverage language in the LCD to
secure Medicare coverage for EsoGuard.
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
