EsoGuard® continues to demonstrate
excellent esophageal precancer and cancer detection performance,
including in most prevalent and challenging precancer
subgroup—short segment non-dysplastic Barrett's Esophagus
EsoCheck® cell collection performed
with 98 percent technical success and high DNA yields in real-world
study of 1483 patients
NEW
YORK, May 11, 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 findings from two
clinical studies of its EsoGuard® Esophageal DNA Test
and EsoCheck® Cell Collection Device, presented at this
week's Digestive Disease Week (DDW) 2023 conference—the world's
premier meeting for digestive disease professionals.
"We are excited that Lucid had a strong presence and it's
technologies garnered widespread interest at this year's DDW
conference," said Suman Verma, M.D.,
Ph.D., Lucid Senior Vice President, and Chief Scientific Officer.
"The excellent EsoGuard and EsoCheck data presented at the
conference strongly support recently updated professional society
guidelines that have established non-endoscopic biomarker testing,
such as EsoGuard performed on samples collected with EsoCheck, as
an acceptable alternative to endoscopy to serve as a widespread
tool to detect esophageal precancer,"
"EsoGuard's overall sensitivity remains excellent, including the
detection of one patient with silent esophageal cancer; it's
performance in short segment Barrett's Esophagus (BE)—the most
prevalent esophageal precancer subgroup and most challenging to
detect—is particularly impressive. This success can be attributed
to EsoGuard's unrivaled ability to detect even the earliest
epigenetic changes in esophageal precancer, as well as EsoCheck's
proprietary Collect+Protect® technology's ability to
provide anatomically precise, and protected sampling of lower
esophageal cells," said Dr. Verma.
"We are also gratified that the tolerability, technical success
rate and DNA yield of EsoCheck cell sampling, documented in a very
large real-world cohort, remains very high. We believe these data
confirm the potential for EsoGuard, performed on samples collected
with EsoCheck, to prevent highly lethal esophageal cancer through
widespread precancer detection," Dr. Verma added.
Acceptability of Non-endoscopic Screening for Barrett's
Esophagus (BE) Among Veterans Eligible for Screening
Sixty-nine patients at the Louis Stokes Cleveland VA Medical
Center underwent non-endoscopic esophageal precancer biomarker
testing followed by confirmatory upper endoscopy as part of a
prospective investigator initiated clinical trial. All but
one patient (99 percent) underwent successful noninvasive
esophageal cell sampling using the EsoCheck device.
EsoGuard sensitivity was 100 percent and all seven patients with
endoscopically documented esophageal precancer or cancer were
detected by EsoGuard. Six of the seven had early precancerous
non-dysplastic BE—four with short segment BE and two with long
segment BE. The seventh patient had a previously silent Stage III
esophageal cancer (adenocarcinoma) detected and treated with
chemotherapy and radiation. The estimated negative predictive value
(NPV), and positive predictive value (PPV), based on the expected
prevalence in a screening population, were 100 percent and 37
percent, respectively, and consistent with generally accepted
targets for a widespread screening tool.
Real World Data Using EsoCheck, a Non-endoscopic
Esophageal Cell Collection Device for Early Detection of Barrett
Esophagus and Esophageal Adenocarcinoma
Data from a real-world cohort of 1,483 patients who underwent
EsoCheck esophageal cell sampling by trained nurse practitioners
were retrospectively analyzed. The findings were consistent with a
previous analysis in a smaller cohort presented last year at the
American Association for Cancer Research (AACR) conference.
Non-invasive, non-endoscopic, in-office EsoCheck cell sampling
was successfully performed in 98 percent of patients, in less than
three minutes on average. It was broadly well-tolerated with 86
percent of patients reporting no, or no more than a mild gag
reflex. Upgrades to the laboratory's DNA extraction procedure,
implemented since the last report, resulted in substantial
improvements in DNA yield, with the proportion of patients with
insufficient DNA falling from six percent to two percent.
About Lucid Diagnostics
Lucid Diagnostics Inc. is a
commercial-stage, cancer prevention medical diagnostics company,
and subsidiary of PAVmed Inc. 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, is
the first and only commercially available diagnostic test capable
of serving as a widespread screening tool to prevent cancer and
cancer deaths through early detection of esophageal precancer in
at-risk GERD patients.
For more information, please visit luciddx.com and for
more information about its parent company PAVmed, please
visit 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 Diagnostics'
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 Diagnostics'
common stock; general economic and market conditions; the
uncertainties inherent in research and development, including the
cost and time required to advance Lucid Diagnostics' products to
regulatory submission; whether regulatory authorities will be
satisfied with the design of and results from Lucid Diagnostics'
clinical and preclinical studies; whether and when Lucid
Diagnostics' products are cleared by regulatory authorities; market
acceptance of Lucid Diagnostics' products once cleared and
commercialized; Lucid Diagnostics' ability to raise additional
funding as needed; and other competitive developments. In addition,
Lucid Diagnostics continues to monitor the COVID-19 pandemic and
the pandemic's impact on Lucid Diagnostics' businesses. These
factors are difficult or impossible to predict accurately and many
of them are beyond Lucid Diagnostics' 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
Diagnostics' future operations, see Part I, Item 1A, "Risk
Factors," in Lucid Diagnostics' most recent Annual Report on Form
10-K filed with the Securities and Exchange Commission. Lucid
Diagnostics 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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