Lucid Diagnostics’ EsoGuard Esophageal DNA Test Wins “Diagnostics Innovation of the Year” Award
October 28 2021 - 8:30AM
Business Wire
BioTech Breakthrough’s Annual Awards Program
Recognizes Innovation in the Global Life Sciences and Biotechnology
Industry
Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid”) a
commercial-stage, cancer prevention medical diagnostics company,
and subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (“PAVmed”),
today announced its EsoGuard® Esophageal DNA Test has been selected
as winner of the “Diagnostics Innovation of the Year” award in the
inaugural awards program conducted by BioTech Breakthrough, a
leading independent market intelligence organization that evaluates
and recognizes standout life sciences and biotechnology companies,
products and services around the globe.
“We are honored to have Lucid’s EsoGuard recognized as BioTech
Breakthrough’s inaugural ‘Diagnostics Innovation of the Year’,”
said Lishan Aklog M.D., Lucid’s Chairman and Chief Executive
Officer. “This award adds to a growing list of accolades and
recognition for Lucid’s products, including a prestigious 2020
Edison Best New Product Award, a National Cancer Institute
highlight as one of the year’s significant advances in cancer
prevention in its 2020 report to Congress, and FDA Breakthrough
Device Designation indicating the potential to offer more effective
diagnosis or treatment of life-threatening diseases.”
“We believe EsoGuard, the first and only commercially available
diagnostic test capable of serving as a widespread screening tool
to prevent esophageal cancer deaths through early detection of
precancer, could have as great an impact as widespread screening
has had in preventing breast, colon, and cervical cancer deaths,”
Dr. Aklog added.
The mission of the annual BioTech Breakthrough Awards program is
to conduct the industry’s most comprehensive analysis and
evaluation of the top technology companies, solutions, and products
in the life sciences and biotechnology industry today. This year’s
program attracted more than 1,200 nominations from over 12
different countries throughout the world.
“Lucid Diagnostics is empowering clinicians to save lives by
accurately detecting esophageal precancer in an office setting at a
stage when it can be effectively managed or treated to prevent
progression to highly lethal esophageal cancer,” said Bryan Vaughn,
Managing Director of BioTech Breakthrough Awards. “Congratulations
on being our choice for the ‘Diagnostics Innovation of the Year
award.”
Gastroesophageal reflux disease (GERD), also known as chronic
heartburn, is ubiquitous and can lead to a highly lethal form of
esophageal cancer (EAC). Over 80% of EAC patients die within five
years of diagnosis, making it the second most lethal cancer in the
U.S. The U.S. incidence of EAC has increased 500% over the past
four decades, while the incidences of other common cancers have
declined or remained flat. In nearly all cases, EAC silently
progresses until it manifests itself with new symptoms of advanced
disease.
All EAC is believed to arise from esophageal precancer which
occurs in up to 5% to 15% of at-risk GERD patients. Early
esophageal precancer can be monitored until it progresses to late
esophageal precancer which can be cured with endoscopic esophageal
ablation, reliably halting progression to cancer. Screening is
already recommended by clinical practice guidelines in many
millions of GERD patients with multiple risk factors, including age
over 50 years, male gender, White race, obesity, smoking history,
and a family history of esophageal precancer or cancer.
Unfortunately, less than 10% of those recommended for screening
undergo traditional invasive endoscopic screening. The profound
tragedy of an EAC diagnosis is that likely death could have been
prevented if the at-risk GERD patient had been screened and then
undergone surveillance and curative treatment. The only missing
element for a viable esophageal cancer prevention program has been
the lack of a widespread screening tool that can detect esophageal
precancer. Lucid believes EsoGuard is that missing element.
EsoGuard is a bisulfite-converted next-generation sequencing
(NGS) DNA assay performed on surface esophageal cells collected
with EsoCheck. It quantifies methylation at 31 sites on two genes,
Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a
408-patient multicenter case-control study published in Science
Translational Medicine and showed greater than 90% sensitivity and
specificity at detecting esophageal precancer and cancer. EsoGuard
is commercially available in the U.S. as a Laboratory Developed
Test (LDT) performed at a CLIA/CAP-certified laboratory. At-risk
GERD patients can undergo the EsoCheck procedure for EsoGuard
testing at gastroenterology physician offices or at a growing
network of Lucid Test Centers.
About Lucid Diagnostics
Lucid Diagnostics Inc. (Nasdaq: LUCD) 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 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, is
the first and only commercially available diagnostic test capable
of serving as a widespread screening tool to prevent cancer and
cancer deaths through early detection of esophageal precancer in
at-risk GERD patients. EsoGuard is commercialized in the U.S. as a
Laboratory Developed Test (LDT). EsoCheck is commercialized in the
U.S. as a 510(k)-cleared esophageal cell collection device.
EsoGuard, used with EsoCheck, was granted FDA Breakthrough Device
designation and is the subject of two large, actively enrolling,
international multicenter clinical trials to support FDA PMA
approval. Lucid is building a network of Lucid Test Centers where
at-risk GERD patients can undergo the EsoCheck procedure for
EsoGuard testing.
Forward-Looking Statements
This press release includes forward-looking statements.
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
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 has been monitoring
the COVID-19 pandemic and the pandemic’s impact on Lucid’s
businesses. Lucid expects the significance of the COVID-19
pandemic, including the extent of its effect on its financial and
operational results, to be dictated by, among other things, the
success of efforts to contain the pandemic and the impact of such
efforts on Lucid’s businesses. All of 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
Lucid’s registration statement on Form S-1 filed with the
Securities and Exchange Commission. 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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Investors Lisa DeScenza
LaVoieHealthScience (617) 351-0243
ldescenza@lavoiehealthscience.com
Media Kristi Bruno
LaVoieHealthScience (617) 865-3940
PAVmed@lavoiehealthscience.com
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