Prospective VA screening study demonstrates
excellent EsoGuard sensitivity of 92.9% and negative predictive
value of 98.6% compared to upper gastrointestinal endoscopy
Authors conclude that EsoGuard is a "powerful
screening tool" for esophageal precancer and cancer
NEW
YORK, March 21, 2024 /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
investigators at the Louis Stokes Cleveland Veterans Affairs
Medical Center, led by Katarina B.
Greer, M.D.,M.S., Associate Professor of Medicine at
Case Western Reserve University School
of Medicine, have released data from a Department of Defense funded
prospective clinical validation study of patients who met strict
national society guideline criteria for esophageal precancer
testing. The study demonstrated excellent performance of Lucid's
EsoGuard® Esophageal DNA test for esophageal precancer
detection and is the first to present such clinical validity data
in a screening population. The manuscript entitled
Non-endoscopic screening for Barrett's esophagus and Esophageal
Adenocarcinoma in at risk Veterans is available on the
leading health sciences preprint server, medRxiv, pending peer
review and publication.
"We are grateful to Dr. Greer and her co-investigators for this
sentinel contribution to the clinical evidence supporting EsoGuard
esophageal precancer testing," said Victoria T. Lee, M.D., Lucid's Chief Medical
Officer. "Data from this clinical validation study, the first in an
'intended use' screening population, closely mirror EsoGuard
performance data from two previously reported NCI-funded
case-control clinical validation studies—the original multi-center
study which first introduced the technology, and the recently
completed BETRNet study whose results were posted as a preprint
last year pending peer review and publication. Collectively, these
three clinical validity studies demonstrate excellent EsoGuard
sensitivity and negative predictive value, including unprecedented
performance of a molecular diagnostic test in detecting a
precancer. They strongly support EsoGuard's use as a widespread
screening tool to prevent esophageal cancer through the early
detection of esophageal precancer."
Dr. Lee added, "as previously reported, three published clinical
utility studies have already documented near-perfect concordance
between EsoGuard results and physician referral for upper
gastrointestinal endoscopy. Physicians consistently utilized
EsoGuard results to appropriately triage at-risk patients resulting
in more cost-effective utilization of endoscopy for esophageal
precancer detection. The clinical validity and clinical utility
data, coupled with multiple national society guidelines and
consensus statements supporting EsoGuard esophageal precancer
detection, provides a strong foundation of critical evidence needed
to support broad EsoGuard medical policy coverage and a line of
sight to CMS coverage, in particular."
The manuscript reports on 128 eligible patients with no prior
history of upper gastrointestinal endoscopy (EGD) who met criteria
for esophageal precancer screening based on current American
College of Gastroenterology guidelines (presence of chronic
heartburn and at least three of six additional risk factors—age
over 50 years, male sex, white race, obesity, smoking and positive
family history). 124 patients underwent successful non-endoscopic
esophageal cell sampling using the EsoCheck® Cell
Collection Device followed by EGD. Biopsies were performed during
EGD if esophageal precancer was suspected based on appearance.
Twelve patients with esophageal precancer and two patients with
esophageal cancer were confirmed on endoscopy for an overall
disease prevalence of 12.9%. 111 patients had sufficient DNA for
EsoGuard analysis. EsoGuard sensitivity and specificity were
92.9% and 72.2%, respectively. Negative and positive predictive
were 98.6% and 32.5% respectively. Although specificity was
somewhat lower than in prior studies—likely due to the absence of
routine biopsies of the gastroesophageal junction, absence of
biopsies in patients with minimal or no suspicious areas on EGD, a
higher mean age, and higher proportion of current smokers—a solid
positive predictive value was preserved, resulting in a 2.5-fold
increase in the positive yield of EGD. Good tolerance and
acceptability of EsoCheck cell sampling was also reported.
The authors conclude that "[g]iven the increasing prevalence
of [esophageal cancer]… and improved effectiveness of ablative and
endoscopic resection techniques available to patients with early
stages of disease, this screening platform [EsoGuard] opens the
window to improved prognosis for [esophageal cancer] by increasing
access to minimally invasive, well tolerated office-based
testing."
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, performed on samples
collected in a brief, noninvasive office procedure with its
EsoCheck® Esophageal Cell Collection Device - 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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