New wholly owned Lucid subsidiary now
performing EsoGuard® Esophageal DNA Test in its own new
state-of-the-art CLIA-certified, CAP-accredited clinical
laboratory
Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid”) a
commercial-stage, cancer prevention medical diagnostics company,
and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM,
PAVMZ) (“PAVmed”), today announced that a new, wholly owned
subsidiary of Lucid, LucidDx Labs Inc. (“LucidDx Labs”) has
acquired from ResearchDx, Inc. (“RDx”), a CLIA-certified,
CAP-accredited clinical laboratory operator located in Irvine, CA,
certain licenses and other related assets necessary for LucidDx
Labs to operate its own new CLIA-certified, CAP-accredited clinical
laboratory located in Lake Forest, CA (the “Laboratory”). RDx had
performed Lucid’s EsoGuard® Esophageal DNA Test (“EsoGuard”) since
its transfer from a university research laboratory and its
commercial launch as a Laboratory Developed Test (“LDT”). LucidDx
Labs has begun performing EsoGuard testing at the Laboratory,
including DNA extraction and bisulfite-converted next-generation
sequencing (“NGS”), on surface esophageal cells collected using
Lucid’s EsoCheck® Esophageal Cell Collection Device (“EsoCheck”)
from at-risk patients with Gastroesophageal Reflux Disease
(“GERD”), also known as chronic heartburn or acid reflux.
“This critical milestone is the culmination of a lot of highly
collaborative work over the past few months by our team and our
outstanding partners at ResearchDx,” said Lishan Aklog, M.D.,
Lucid’s Chairman and Chief Executive Officer. “Having our own
CLIA/CAP laboratory to perform EsoGuard testing will markedly
streamline and simplify numerous important processes, including
EsoGuard billing and collections. More fundamentally, it provides
us with a strong, long-term, scalable infrastructure to accommodate
accelerating growth in testing volume from our expanding EsoGuard
commercialization activities.”
LucidDx Labs and RDx also entered into a management services
agreement pursuant to which RDx will continue to provide personnel
and services to support the performance of EsoGuard at the
Laboratory. Concurrently, LucidDx Labs entered into an agreement to
lease the building in Lake Forest, CA where the Laboratory operates
from an affiliate of RDx. The Laboratory has acquired, installed,
and qualified all the necessary technology and equipment to perform
the EsoGuard assay, completed the necessary assay validations to
process clinical samples as an LDT, completed a College of American
Pathologists (“CAP”) audit, and begun performing EsoGuard testing
at the new facility. Protocols to initiate formal transfer of the
Clinical Laboratory Information Act (“CLIA”) certificate as well as
relevant state licenses have commenced. Further details on this
acquisition and the launch of the laboratory can be found in a
Current Report filed today with the Securities and Exchange
Commission on Form 8-K.
About EsoGuard and EsoCheck
Millions of patients with GERD are at risk of developing
esophageal precancer and 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
mortality rate is high even in those diagnosed with early stage
EAC. 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 approximately 5% to 15% of at-risk GERD patients.
Early esophageal precancer can be monitored for progression to late
esophageal precancer which can be cured with endoscopic esophageal
ablation, reliably halting progression to cancer.
Esophageal precancer screening is already recommended by
clinical practice guidelines in 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, fewer 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 and
EsoCheck are the missing element and constitute the first and only
commercially available test capable of serving as a widespread
screening tool to prevent esophageal cancer deaths through the
early detection of esophageal precancer in at-risk GERD
patients.
EsoGuard is a bisulfite-converted NGS DNA assay performed on
surface esophageal cells collected with EsoCheck which 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.
EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive
swallowable balloon capsule catheter device capable of sampling
surface esophageal cells in a less than five-minute office
procedure. It consists of a vitamin pill-sized rigid plastic
capsule tethered to a thin silicone catheter from which a soft
silicone balloon with textured ridges emerges to gently swab
surface esophageal cells. When vacuum suction is applied, the
balloon and sampled cells are pulled into the capsule, protecting
them from contamination and dilution by cells outside of the
targeted region during device withdrawal. Lucid believes this
proprietary Collect+Protect™ technology makes EsoCheck the only
noninvasive esophageal cell collection device capable of such
anatomically targeted and protected sampling. The sample is sent by
overnight express mail to Lucid’s third-party CLIA-certified
laboratory partner for EsoGuard testing.
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 nationwide direct sales and marketing
team targeting primary care physicians, gastroenterologists, and
consumers, as well as 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 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 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. 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 No. 333-259721 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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version on businesswire.com: https://www.businesswire.com/news/home/20220303005401/en/
Investors Adrian K. Miller PAVmed
Inc. AKM@PAVmed.com
Media Shani Lewis
LaVoieHealthScience (609) 516-5761
PAVmed@lavoiehealthscience.com
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