Lucid Diagnostics Launches Stage II Lucid Test Center Expansion in California, Texas, Florida, and Ohio
August 11 2022 - 8:25AM
Business Wire
Patients in Orange County, Dallas-Fort Worth,
Palm Beach County, and Columbus, Ohio now have access to a brief,
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 that its subsidiary, LucidDx
Labs Inc. (“LucidDx Labs”), has launched four new Lucid Test
Centers in Orange County, California, the Dallas-Fort Worth, Texas
metropolitan area, Palm Beach County, Florida and Columbus,
Ohio.
Patients in these metropolitan areas with chronic heartburn,
also known as gastroesophageal reflux disease (“GERD”), and an
order from their own physician or from a telemedicine physician
provided to them after a self-referral, can now undergo a brief,
non-invasive, office-based test to detect esophageal precancer
before it progresses to deadly esophageal cancer, using Lucid’s
EsoGuard® DNA Esophageal Test (“EsoGuard”) on samples collected
using its EsoCheck® Cell Collection Device (“EsoCheck”). Lucid
believes EsoGuard is the first and only commercially available test
capable of serving as a widespread tool to prevent esophageal
cancer deaths, through early precancer detection in at-risk GERD
patients.
“We are excited to launch the second stage of our Lucid Test
Center program, an important pillar of our growth strategy, in
several new major metropolitan areas including in the three largest
U.S. states,” said Lishan Aklog, M.D., Lucid’s Chairman and Chief
Executive Officer. “During the first stage we covered seven, mostly
medium-sized, metropolitan areas in the Southwest and Pacific
Northwest, which allowed our team to hone our sales processes
targeting primary care physicians and to build a robust compliance
program. With stage two, during which we project to open centers in
nine new metropolitan areas this year, we are establishing a
broader, national footprint using demographic and other analytics
to select high-value target locations across the country. We are
also able to place test centers in locations where existing sales
personnel are already having success calling on specialists and
institutions and where our prospects for local private payor
coverage is strongest as a result of our growing participation in
preferred provider networks.”
The test centers are staffed with Lucid-employed nurse
practitioners who use EsoCheck to collect surface esophageal cells
which are sent to LucidDx Labs for EsoGuard testing. The new Lucid
Test Centers operate in leased medical office suites located in
Lake Forest, California, Las Colinas, Texas, Delray Beach, Florida,
and Columbus, Ohio. The Lake Forest Lucid Test Center is co-located
with LucidDx Labs’ CLIA certified, CAP accredited commercial
clinical laboratory. 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
lease costs with only a few tests per week.
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,
performed on samples collected with EsoCheck, is the missing
element—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. An updated American College of
Gastroenterology clinical practice guideline and an American
Gastroenterological Association clinical practice update both
endorse nonendoscopic biomarker tests as an acceptable alternative
to costly and invasive endoscopy for esophageal precancer
screening. EsoGuard is the only such test currently available in
the United States.
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 CLIA-certified, CAP-accredited
laboratory, LucidDx Labs, 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 multiple ongoing clinical trials.
Lucid is building nationwide direct sales and marketing team
targeting primary care physicians, specialists, and institutions,
as well as a network of Lucid Test Centers where at-risk GERD
patients can undergo the EsoCheck procedure for EsoGuard testing.
For more information, please visit www.luciddx.com, follow Lucid on
Twitter, and connect with Lucid on LinkedIn. For detailed
information on EsoGuard, please visit www.EsoGuard.com and follow
us on Twitter, Facebook and Instagram.
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Investors Adrian K. Miller PAVmed
Inc. AKM@PAVmed.com
Media Shani Lewis
LaVoieHealthScience (609) 516-5761
PAVmed@lavoiehealthscience.com
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