Multicenter observational study documents
excellent concordance of EsoGuard results with subsequent medical
decision-making by multiple physicians
NEW
YORK, Sept. 7, 2023 /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 it has released
positive interim data from the multicenter, CLinical
Utility of EsoGuard (CLUE) study. This is the
Company's first report of prospective data from multiple physicians
demonstrating real-world clinical utility of EsoGuard® Esophageal
DNA testing for the detection of esophageal precancer; and
supplements its recently released positive data from a
retrospective analysis of EsoGuard's clinical utility in
firefighters.
The study documents near perfect concordance, including 100
percent concordance in EsoGuard-positive patients, between
clinically-directed EsoGuard test results and subsequent medical
decision-making by multiple different prescribing physicians. It
demonstrates that EsoGuard allows physicians to appropriately
triage those requiring confirmatory endoscopy in a manner broadly
consistent with established, and recently updated, professional
society guidelines. The manuscript entitled Clinical Utility
Study of EsoGuard® on Samples Collected with
EsoCheck® as a Triage Test for Endoscopy to Identify
Barrett's Esophagus – Interim Data of the First 275
Subjects is available on the leading health sciences
preprint server, medRxiv, pending peer review and publication.
"Prospective clinical utility data involving multiple physicians
provides the strongest level of evidence to payors, and other
stakeholders, that a diagnostic test such as EsoGuard has
real-world clinical utility driving appropriate medical decision
making," said Victoria T. Lee, M.D.,
PAVmed's Senior Vice President and Chief Medical Officer of PAVmed,
who oversees all of Lucid's clinical research activities. "We
designed CLUE to demonstrate to payors that a diverse group of
physicians across multiple centers will clinically utilize EsoGuard
to appropriately refer at-risk patients with positive results for
confirmatory endoscopy, and not refer those with negative results
unless another indication for endoscopy emerges. These outstanding
interim results in our first 275 patients document that the
physicians do make the appropriate referrals, consistent with
professional society guidelines. We continue to expand the number
of study sites and enroll additional patients in the CLUE study. We
plan to release subsequent reports on a larger CLUE cohort along
with additional clinical utility data documenting patient
compliance with the endoscopy referral following a positive
EsoGuard result."
The manuscript reports on the first 275 patients at-risk for
esophageal precancer enrolled in the prospective multicenter CLUE
study at four U.S. sites. 264 patients underwent successful
nonendoscopic esophageal cell sampling using Lucid's
EsoCheck® Cell Collection Device—a 96 percent technical
success rate. Of the 232 patients for whom results were available
220 had sufficient DNA (95 percent) for EsoGuard testing. The
prescribing physician referred all 68 patients with positive
EsoGuard results (29 percent) for confirmatory endoscopy. 151 of
the 152 patients with negative EsoGuard results were not referred
for endoscopy. One EsoGuard-negative patient was referred for
endoscopy as part of a surgical evaluation, not for precancer
screening. These results document 100 percent concordance between a
positive EsoGuard test result and subsequent physician medical
decision-making, and a 99 percent concordance with a negative
result. EsoGuard eliminated the need for over one-hundred fifty
costly, invasive, and inconvenient endoscopies at the four
practices, consistent with professional society guidelines.
"These outstanding results add to a growing evidence base of
EsoGuard's clinical utility and clinical validity, which was
recently strengthened by unprecedented esophageal precancer and
cancer detection results from the NCI-funded BETRNet study," said
Lishan Aklog, M.D., Lucid's Chairman
& Chief Executive Officer. "We look forward to using these data
to accelerate our engagement with payors and continuing to expand
EsoGuard's clinical utility and clinical validity evidence base
over the coming quarters."
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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SOURCE Lucid Diagnostics