EsoGuard demonstrated unprecedented early
precancer detection, including 89% sensitivity at detecting short
segment early precancer, the primary target of esophageal precancer
testing
Publication further strengthens EsoGuard's
clinical data supporting ongoing engagement to secure commercial
and Medicare payor coverage
NEW
YORK, May 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 the peer-reviewed publication of
positive data from a National Cancer Institute (NCI)-sponsored,
prospective, multicenter clinical validation study assessing the
performance of Lucid's EsoGuard® Esophageal DNA Test on
samples collected with its EsoCheck® Esophageal Cell
Collection Device. This case-control study, led by Case Western Reserve University's Amitabh Chak,
M.D., was funded through the NCI's Barrett's Esophagus
Translational Research Network (BETRNet), and included renowned
investigators from leading academic medical centers, including
Case Western Reserve University, Mayo
Clinic, Johns Hopkins University,
Washington University in St. Louis, University of
North Carolina, and Cleveland Clinic. EsoGuard demonstrated
unprecedented early precancer detection compared to the gold
standard of upper endoscopy (EGD). The manuscript, entitled
Multicenter, Prospective Trial of Non-Endoscopic
Biomarker-Driven Detection of Barrett's Esophagus And Esophageal
Adenocarcinoma, was published in the American Journal of
Gastroenterology, the leading clinical journal covering
gastroenterology published on behalf of the American College
of Gastroenterology (ACG).
"We owe a debt of gratitude to Dr. Chak and his BETRNet
co-investigators for their contributions to this landmark study,
which we believe represents a pivotal step towards our goal of
eliminating the scourge of esophageal cancer," said Lishan Aklog, M.D., Lucid's Chairman and Chief
Executive Officer. "EsoGuard's unprecedented ability to
noninvasively detect early ("non-dysplastic") precancer is a
remarkable scientific and technological accomplishment. Its high
sensitivity and estimated negative predictive value (NPV) are
hallmarks of a powerful early detection test. What was particularly
striking was its 89% sensitivity in short-segment non-dysplastic
precancers (SSBE), which account for at least 70% of cases in a
screening population and are responsible for at least half of all
future cancers. Effective esophageal cancer prevention requires
high SSBE sensitivity. EsoGuard's 89% SSBE sensitivity is in stark
contrast to the 63% SSBE sensitivity documented in a recent
research report on methylation markers using decades-old
sponge-on-a-string (SOS) technology. We believe this stark
difference reflects both the superiority of EsoGuard's precision
next generation sequencing (NGS) assay and EsoCheck's
groundbreaking, patent-protected Collect+Protect™ technology, which
provides anatomically targeted and protected sampling, without the
contamination and dilution inherent in SOS devices."
Dr. Aklog concluded, "The publication of the BETRNet study is
the culmination of a period of rapid expansion of EsoGuard's
clinical evidence base. It represents the second peer-reviewed, and
third overall, clinical validation study demonstrating consistently
excellent EsoGuard performance. Soon to be released data from a
fourth such clinical validation study tells the same story. These
powerful clinical validity data are supplemented by three
previously published clinical utility studies demonstrating
near-perfect concordance between EsoGuard results and appropriate
physician referral behavior, avoiding invasive endoscopy in a large
majority of patients. Although the pipeline of future EsoGuard and
EsoCheck clinical studies is robust, we believe we have reached a
critical threshold and now have a complete package of clinical
validity and utility data to accelerate our efforts to garner
widespread EsoGuard payor coverage. In particular, this
peer-reviewed publication allows us to proceed with our stated plan
to seek Medicare coverage. We intend to review our data with MolDX
at an upcoming pre-submission meeting, and then submit a formal
technical assessment ("TA") seeking EsoGuard coverage under MolDX's
final and effective foundational local coverage determination on
Molecular Testing for Detection of Upper Gastrointestinal
Metaplasia, Dysplasia, and Neoplasia. We continue to remain
optimistic that we have a line of sight to Medicare coverage."
In summary, the BETRNet study (ClinicalTrials.gov NCT00288119)
included 243 evaluable patients enrolled prospectively across
six academic medical centers within the BETRNet consortium—155
control patients free of esophageal precancer (Barrett's Esophagus
or BE) or cancer, and 88 patients with conditions along the
spectrum from early precancer (non-dysplastic BE) to late precancer
(indeterminate for dysplasia, and low-grade or high-grade
dysplastic BE) to cancer (adenocarcinoma). Study patients underwent
both EsoCheck esophageal cell collection (average procedure time
2.5 minutes) and upper endoscopy (EGD) with biopsies obtained as
clinically indicated. Overall patient tolerance and satisfaction
with EsoCheck was excellent. EsoCheck samples were sent to LucidDx
Labs, Inc. (Lake Forest, CA) for
EsoGuard testing. EsoGuard performance was excellent when compared
to EGD. EsoGuard detected 100% of the patients with cancer. Overall
sensitivity and specificity were each 85%. Based on an expected BE
prevalence of approximately 10% in a population with
gastroesophageal reflux disease (GERD) and additional risk factors,
the authors estimated EsoGuard's negative predictive value (NPV)
and positive predictive value (PPV) to be 98% and 39%,
respectively. This performance is consistent with a robust early
detection or screening test. Most importantly, sensitivity for
short-segment precancer (SSBE), the primary target of esophageal
precancer testing accounting for over half of future cancers, was
89%—unprecedented for the detection of early precancers of limited
anatomic extent. The authors conclude that "EsoCheck/EsoGuard
demonstrated high sensitivity and specificity in detecting BE and
BE-related neoplasia [cancer]…These results enable the more
wide-spread screening of at-risk patients for BE, as recommended in
the most recent ACG Guideline and AGA Clinical Update."
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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