Patients in Denver, Salt Lake City, and Las
Vegas metropolitan areas now have access to a rapid, non-invasive,
office-based test to detect esophageal precancer before it
progresses to deadly esophageal cancer
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 it has launched Lucid Test
Centers in three new metropolitan areas—Denver, Salt Lake City, and
Las Vegas. Patients in these cities with chronic heartburn, also
known as gastroesophageal reflux disease (“GERD”), who are referred
by their primary care physician (PCP) or who self-refer can now
undergo a rapid, non-invasive, office-based test to detect
esophageal precancer before it progresses to deadly esophageal
cancer. The test centers are staffed with Lucid-employed clinical
personnel who use Lucid’s EsoCheck® Cell Collection Device
(“EsoCheck”) to collect surface esophageal cells which are sent for
Lucid’s EsoGuard® DNA Esophageal Test (“EsoGuard”). Lucid believes
EsoGuard and EsoCheck 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.
“This launch represents another significant milestone for Lucid
and our EsoGuard commercialization efforts,” said Lishan Aklog
M.D., Lucid’s Chairman and Chief Executive Officer. “The Lucid Test
Center program, an important pillar of our growth strategy, has now
advanced from a pilot program in Phoenix to a regional program
covering the major cities of the Southwest. We look forward to the
next phase which will focus on the Pacific Northwest and steady
expansion nationwide thereafter.”
“We believe these Lucid Test Centers will play a vital role in
driving EsoGuard referrals, as the vast majority of GERD patients
are cared for by PCPs, not gastroenterologists. Our Phoenix
experience over the past three months has demonstrated that each
test center can be operated with very modest fixed costs and
attractive margins. We also learned that the key to driving PCP
EsoGuard referrals is matching each test center with experienced,
highly-driven sales representatives, most commonly from the
diagnostics or pharmaceutical sectors, who exclusively call on
PCPs,” Dr. Aklog added.
The new Lucid Test Centers operate in leased medical office
suites located in Lone Tree, Colorado, Murray, Utah, and Henderson,
Nevada. Each test center is staffed by an EsoCheck-trained nurse
practitioner and medical assistant employed by Lucid. Lucid
estimates that a single nurse practitioner can perform up to twenty
EsoCheck procedures per day and expects each center to cover its
personnel and medical office leases costs with only a few tests per
week.
Lucid has hired six very experienced sales representatives
targeting PCP’s—two for each metropolitan area. The test centers
will also support the upcoming EsoGuard Telemedicine Program,
operated in partnership with independent third-party telemedicine
provider UpScript, to accommodate EsoGuard self-referrals from
direct-to-consumer marketing. The telemedicine program will soon
launch as a pilot in Phoenix and similarly expand to other test
center cities.
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 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.
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 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. 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 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/20211111005683/en/
Investors Lisa DeScenza
LaVoieHealthScience (617) 351-0243
ldescenza@lavoiehealthscience.com
Media Kristi Bruno
LaVoieHealthScience (617) 865-3940
PAVmed@lavoiehealthscience.com
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