Clinical registries are collecting real-world
clinical utility and clinical validity data on EsoGuard
testing in general at-risk populations and firefighters,
respectively
Initial combined analysis of clinical utility
in 437 patients documents excellent concordance of EsoGuard
results with subsequent medical decision-making and over 99 percent
technical success
NEW
YORK, Oct. 31, 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 two longitudinal
clinical registries which are collecting real-world clinical
utility and clinical validity data on EsoGuard®
Esophageal DNA testing for the detection of
esophageal precancer. The Prospective REView of
Esophageal Precancer DetectioN in AT-Risk
Patients (PREVENT) Registry collects data on EsoGuard testing in
the general at-risk population, while the PREVENT-FF Registry
focuses exclusively on at-risk firefighters. The Company released
positive clinical utility data from an initial combined analysis of
patients from both registries.
The PREVENT Registry prospectively enrolls patients with
well-established esophageal precancer risk-factors referred by
a physician to Lucid for EsoGuard testing. Lucid clinical personnel
perform esophageal cell collection using the EsoCheck®
Cell Collection Device and Lucid's CLIA-certified laboratory then
performs the EsoGuard test on the sample. Subsequent management,
including referral for upper endoscopy, is dictated exclusively by
the referring physician. The PREVENT-FF Registry prospectively
enrolls firefighters with additional esophageal precancer risk
factors referred for EsoGuard testing who participate in one of
Lucid's #CheckYourFoodTube Precancer Testing Events. A total of 624
patients have been enrolled in the two registries to date.
"PREVENT and PREVENT-FF are key pillars of our commercial
strategy for EsoGuard and we are excited to see the initial fruits
of our investment in these real-world clinical registries," said
Lishan Aklog, M.D., Lucid's Chairman
& Chief Executive Officer. "The initial combined analysis will
supplement our growing clinical utility evidence base, including
the previously announced CLUE and San Antonio Firefighter studies.
The PREVENT and PREVENT-FF registries, however, are designed to
generate a much broader data set than these clinical utility
studies. The registries are open-ended, and our goal is to enroll a
substantial proportion of all patients undergoing EsoGuard testing
by Lucid personnel at Lucid Test Centers, including satellite
testing at physician offices, and health fairs, including at fire
departments. They also penetrate much further into the patient
journey than the previously reported studies by going beyond the
initial medical decision-making. The registries have a meaningful
longitudinal follow-up period and include confirmatory endoscopy
findings in those with positive EsoGuard results. As a result, they
will provide both clinical utility and clinical validity data to
further support our ongoing commercial and market access efforts,
including our critical, expanding engagement with commercial
payors. The full data set will also feed our active research and
development program on the EsoGuard assay and a pipeline of
potential future commercial products. Finally, the PREVENT-FF
registry is a testament to our deep commitment to provide access to
early precancer detection to reduce the tragic toll that cancer
inflicts on firefighters who sacrifice so much for us."
A manuscript on the initial analysis combining clinical utility
data from both registries, entitled Real World Experience
and Clinical Utility of EsoGuard® - Interim Data from
the Lucid Registry, was recently posted on the leading health
sciences preprint server, medRxiv, and has been submitted for
peer-reviewed publication. Of the 517 patients enrolled at the date
of this manuscript, over 304 were firefighters and 437 had complete
clinical utility data. EsoCheck cell collection was technically
successful in 99.6 percent and sufficient DNA was collected in over
95 percent, replicating near-perfect technical success rates and
high DNA yields previously reported by Lucid. The mean cell
collection time was less than two minutes, besting prior reports.
The prescribing physician referred all 55 patients with positive
EsoGuard results (14 percent) for confirmatory endoscopy. 352 of
the 354 patients with negative EsoGuard results were not referred
for endoscopy. This represents 100 percent concordance between a
positive EsoGuard test result and subsequent physician medical
decision-making, and a 99.4 percent concordance with a negative
result, consistent with professional society guidelines. These
outstanding clinical utility results align with the previously
announced CLUE and San Antonio Firefighter studies. They again
demonstrate that EsoGuard allows physicians to appropriately triage
at-risk patients to confirmatory endoscopy in a manner broadly
consistent with established, and recently updated, professional
society guidelines, in this case, eliminating the need for over 350
costly, invasive, and inconvenient endoscopies.
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 is
performed on samples collected in a brief, noninvasive office
procedure with its EsoCheck® Esophageal Cell
Collection Device. EsoGuard and EsoCheck are 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