Real-world data confirms utility of EsoGuard
as a non-invasive triage tool to significantly increase positive
yield of invasive upper endoscopy
NEW
YORK, Aug. 6, 2024 /PRNewswire/ -- Lucid
Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or
the "Company"), a commercial-stage, cancer prevention medical
diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM),
today announced the release of new real-world data from its
ENVET-BE study supporting the clinical utility of the
EsoGuard® Esophageal DNA test as a
non-invasive triage tool to significantly increase the positive
yield of invasive upper endoscopy (EGD) for detection of esophageal
precancer (Barrett's Esophagus or BE) and cancer. The manuscript
entitled Enhancing the Positive Predictive Value of EGD for
Diagnosis of Barrett's Esophagus Through EsoGuard®
Triage, is currently available on the leading health sciences
preprint server, MedRxiv, while undergoing peer review for
publication. Patients triaged to invasive EGD following a positive
non-invasive EsoGuard test had a 2.4-fold increase in the positive
yield of those EGDs compared to the expected yield of screening EGD
alone in at-risk patients.
"Up to 90% of esophageal cancer patients were never previously
diagnosed with esophageal precancer," said ENVET-BE investigator
Jayde E. Kurland, M.D., FACG, AGAF,
a gastroenterologist and advanced endoscopist at Gastro
Health in Lima, OH. "We
found we were missing ~80% of patients in our busy endoscopy
practice who should be eligible for esophageal
precancer screening based on risk factors and gastroenterology
guidelines. This study demonstrates that EsoGuard triage
allows us to efficiently screen more patients, significantly
improves the yield of endoscopy, and increases our ability to
diagnose and treat disease before it develops into cancer. We
have fully incorporated EsoGuard in our practice and believe it
will serve a crucial role in esophageal precancer screening."
EGD confirmed a BE diagnosis in 50 of the 199 patients in a
real-world commercial setting who underwent clinically directed
EsoGuard testing and received a positive EsoGuard result.
This represents a post-triage EGD yield of 25%, a 2.4-fold increase
over the expected 11% yield of EGD as a standalone screening tool
in the at-risk population. These findings are consistent with those
previously published by Greer et. al. in the American Journal of
Gastroenterology for a study conducted at the Cleveland VA that utilized EsoGuard for
screening high-risk veterans.
"The ENVET-BE study demonstrates that triaging at-risk patients
with EsoGuard significantly increases the yield of EGD, which
should lead to more efficient use of endoscopy resources while
improving early detection of esophageal precancer,"
said Victoria T. Lee, M.D.,
Lucid's Chief Medical Officer. "These results support published
professional society guidelines which include non-endoscopic
biomarker tests, such as EsoGuard, as an acceptable alternative to
EGD for esophageal precancer testing. Using EsoGuard to triage
patients to EGD has the potential to increase compliance with
esophageal precancer screening guidelines and reduce esophageal
cancer deaths."
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, represent
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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SOURCE Lucid Diagnostics