Prospective screening study demonstrates
excellent EsoGuard sensitivity of 87.5% and negative predictive
value (NPV) of 98.6%
Previously announced positive data from a
separate prospective VA screening study also accepted for
peer-reviewed publication
Studies further strengthen EsoGuard's clinical
validity data in support of upcoming Medicare LCD pre-submission
meeting and ongoing commercial payor engagements
NEW
YORK, July 2, 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), today announced positive data from its ESOGUARD
BE-1 prospective, international, multicenter, single-arm study
conducted to clinically validate performance of the
EsoGuard® Esophageal DNA test on samples collected
with the EsoCheck® Esophageal Cell Collection Device for
detection of esophageal precancer (Barrett's Esophagus or BE) and
esophageal adenocarcinoma (EAC) in a screening population. This is
the second clinical validation study in a screening population
following previously announced positive data from the Cleveland VA screening study, which was
recently accepted for peer-reviewed publication.
The ESOGUARD BE-1 study was led by Nicholas J. Shaheen, M.D., M.P.H., Professor of
Medicine and Epidemiology at the University of
North Carolina School of Medicine, a leading esophageal
precancer expert and lead author of the American College of
Gastroenterology (ACG) guidelines on esophageal precancer
screening. Study sites included leading academic medical centers,
such as Baylor College of Medicine,
University of California-Irvine,
Vanderbilt University, and University of Utah, as well as other notable U.S.
and European centers. The manuscript entitled Use of the
EsoGuard® Molecular Biomarker Test in Non-Endoscopic
Detection of Barrett's Esophagus among High-Risk Individuals in a
Screening Population demonstrated high sensitivity and
negative predictive value (NPV) compared to upper gastrointestinal
endoscopy and is currently available on the leading health sciences
preprint server, MedRxiv, pending peer review and publication.
The manuscript for the Cleveland
VA screening study, entitled Non-endoscopic screening for
Barrett's esophagus and Esophageal Adenocarcinoma in at risk
Veterans, has been accepted for peer-reviewed publication in
the American Journal of Gastroenterology.
"We are grateful to Dr. Shaheen and his co-investigators for
this valuable contribution to the clinical evidence supporting
EsoGuard esophageal precancer testing," said Victoria T. Lee, M.D., Lucid's Chief Medical
Officer. "This second multi-center clinical validation study in an
intended use screening population demonstrates nearly
identical EsoGuard performance compared to two previously reported
National Cancer Institute (NCI)-funded case-control
studies—a multi-center pivotal study published in Science
Translational Medicine introducing the technology and a
multi-center study from the BETRNet consortium recently
published in the American Journal of Gastroenterology.
Additionally, the previously announced and now peer-reviewed
results of the Cleveland VA
screening study demonstrated an identical NPV, and a similar
sensitivity of 92.9%. Collectively, these four clinical validity
studies demonstrate an 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 that physicians consistently utilized EsoGuard results
to appropriately triage at-risk patients, which can result in more
cost-effective utilization of endoscopy for esophageal precancer
detection. These clinical validation and clinical utility data,
coupled with multiple national society guidelines and consensus
statements supporting non-endoscopic esophageal precancer
detection, provides a robust clinical evidence base in support of
our upcoming Medicare LCD pre-submission meeting and ongoing
commercial payor engagements."
The BE1 manuscript reports EsoGuard performance in 93 subjects
who met criteria for esophageal precancer screening based on
American College of Gastroenterology (ACG) 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), underwent EsoCheck cell collection,
had binary EsoGuard results, and a definitive final diagnosis
established by upper gastrointestinal endoscopy and biopsies. Of
these 93 subjects contributing to the primary endpoint analysis,
eight had BE without dysplasia, for a disease prevalence of 8.6%.
No subjects with EAC were identified. EsoGuard sensitivity for BE
was 87.5%, specificity was 81.2%, positive predictive value was
30.4%, and negative predictive value was 98.6%.
The authors conclude that "…EsoGuard DNA biomarker
testing was well-tolerated, convenient, safe, and efficient…with a
PPV and a NPV that can appropriately guide clinical
decision-making…Improved accessibility of non-endoscopic, in-office
testing could increase BE screening rates, improve early disease
detection, and ensure BE patients receive appropriate endoscopic
surveillance and treatment to avoid progression to EAC."
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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