EsoGuard 2.0 incorporates advanced molecular
techniques and leverages improvements in sample DNA yields and
processes to enhance assay performance and lower costs
Lucid Diagnostics Investor Day, where Lucid
executives, key opinion leaders, and other experts will discuss
Lucid's business and technologies, to be held in New York City on December 13th
NEW
YORK, Nov. 9, 2023 /PRNewswire/ -- Lucid
Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the
"Company") a commercial-stage, cancer prevention medical
diagnostics company, and majority-owned subsidiary of PAVmed Inc.
(Nasdaq: PAVM, PAVMZ) ("PAVmed"), today announced that its
CAP-accredited, CLIA-certified laboratory, LucidDx Labs, Inc., has
launched the next generation of the EsoGuard® Esophageal
DNA test ("EsoGuard 2.0") for the detection of esophageal
precancer, having demonstrated enhanced assay performance and lower
costs in extensive validation studies. All commercial and research
samples received by the laboratory will now be processed using the
EsoGuard 2.0 assay. Lucid also announced that it will be hosting an
Investor Day on December 13, 2023, in
New York City.
"The launch of EsoGuard 2.0 is a seminal milestone for our
company and the culmination of over a year of meticulous R&D
work by our Chief Scientific Officer, Suman Verma, M.D, Ph.D., and her dedicated and
talented team," said Lishan Aklog,
M.D., Lucid's Chairman & Chief Executive Officer. "EsoGuard had
previously demonstrated unprecedented cancer and precancer
detection results, including detecting 100 percent of esophageal
cancers and over 80 percent of precancers in a recent study from
the National Cancer Institute-funded BETRNet consortium. EsoGuard
2.0 improves upon EsoGuard 1.0's already outstanding performance in
multiple respects, including by enhancing DNA yield, streamlining
down-stream processes that incorporate advanced molecular
techniques and more efficient bioinformatics, and enabling
higher-throughput testing. These improvements also lower the
per-sample costs of the assay, which we expect to decrease even
further in the coming months when we upgrade our NGS-sequencing
platform to a higher-throughput model to accommodate increased
EsoGuard testing volume. We appreciate the critical input of
Sandy Markowitz, M.D., Ph.D., and
his colleagues at Case Western Reserve
University, the inventors of EsoGuard, in helping us reach
this milestone."
The results of the analytical validation studies of the EsoGuard
assay, culminating in EsoGuard 2.0, have been accepted for
presentation at the upcoming Association of Molecular Pathology
Annual Meeting (AMP 2023) on November
18th.
The EsoGuard assay involves first extracting DNA from esophageal
cells collected by the EsoCheck® Cell Collection Device.
The DNA then undergoes bisulfite conversion, which tags sites which
are not methylated. Two genes, VIM and CCNA1, with 31 methylation
sites that correlate with esophageal precancer and cancer, are
amplified using polymerase chain reaction ("PCR") techniques and
then sequenced using next-generation sequencing ("NGS") techniques.
Advanced bioinformatics software analyzes the DNA sequence data and
determines the proportion of the 31 target sites which are
methylated, returning a positive or negative EsoGuard result. The
original version of the assay used a singleplex technique, which
required the DNA to be split and separately processed for each
gene. EsoGuard 2.0 uses multiplexing which allows both genes to be
interrogated on a single DNA sample. This breakthrough allows the
laboratory to run the assay three times and call positive and
negative results by consensus, blunting stochastic noise for low
positive samples near the cutoff. The next-generation assay
underwent rigorous analytical and clinical validation studies,
including head-to-head comparisons of multiplexed triplicate
consensus versus singleplex techniques, consistent with CLIA
standards. Clinical validation analysis included samples from the
ESOGUARD-BE-1 study and demonstrated improved sensitivity and
specificity.
Lucid will host an Investor Day event to be held in New York, NY on December 13, 2023. The Lucid executive leadership
team will present on several topics including the company's
commercial progress, the launch of EsoGuard 2.0, and the recent
expansion of clinical utility and clinical validity data to support
adoption and reimbursement. Key opinion leaders in the field of
esophageal disease and other experts will present on their
experiences with EsoGuard and its impact on patient outcomes.
Details on how to register for the Investor Day will be made
available on the Investor Relations section of the Company's
website.
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 is performed on samples
collected in a brief, noninvasive office procedure with its
EsoCheck® Esophageal Cell Collection Device.
EsoCheck and EsoGuard are 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