Study demonstrates outstanding clinical
utility including an exceptionally high 85% patient compliance with
referral to confirmatory upper endoscopy following EsoGuard
esophageal precancer testing
NEW
YORK, Dec. 11, 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 that the manuscript for its CLinical
Utility of EsoGuard (CLUE) study has been accepted
for publication in the peer-reviewed journal Medicina. This
is the fourth peer-reviewed publication presenting outstanding
clinical utility data for the EsoGuard® Esophageal DNA
Test. In addition to demonstrating near-perfect provider decision
impact, consistent with previous EsoGuard clinical utility studies,
the study documented an exceptionally high 85% patient compliance
with referral to confirmatory upper endoscopy (EGD) following
EsoGuard esophageal precancer testing in a real-world clinical
setting.
"The final results from the CLUE study strongly support the
clinical utility of EsoGuard as an effective triage
tool for esophageal precancer testing of at-risk patients and
we are deeply grateful to our investigators across eight clinical
centers for their commitment to esophageal cancer prevention," said
Victoria T. Lee, M.D., Lucid's Chief
Medical Officer. "EsoGuard enables physicians to effectively triage
patients at increased risk for esophageal precancer to confirmatory
upper endoscopy. Once again, physicians consistently utilized our
non-invasive EsoGuard test to appropriately refer patients to
endoscopy, allowing the vast majority of patients to avoid this
more expensive and invasive procedure. Patients, in turn, showed an
exceptionally high level of compliance with their physician's
referral to EGD. This patient compliance data and the study's full
provider impact data supplements our strong evidence base of
clinical validity, clinical utility and analytical validity data
supporting our ongoing discussions with payors and other key
stakeholders."
The full manuscript, entitled Real-world Clinical Utility of
a Methylated DNA Biomarker Assay on Samples Collected with a
Swallowable Capsule-balloon for Detection of Barrett's Esophagus
(BE) is expected to be available in an upcoming online edition
of Medicina, and follows the CLUE interim data report which
was previously published in the Archives of Clinical and
Biomedical Research in December of 2023.
The prospective, multicenter CLUE study enrolled patients who
met gastroenterology society guideline criteria for esophageal
precancer screening from eight clinical centers. A total of 502
patients contributed to the clinical utility endpoints. The study
demonstrated strong provider decision impact—100% of
EsoGuard-positive patients were referred for confirmatory EGD,
while over 99% of EsoGuard-negative patients were not referred.
Among patients with positive EsoGuard results, compliance with
follow-up EGD was 85%, more than double the patient compliance rate
with screening EGD referral in the published literature. The study
authors concluded that "EsoCheck is easy to implement for
non-endoscopic in-office esophageal cell sampling, and the EsoGuard
methylated DNA assay is effective in guiding provider
decision-making…Patients with positive test results also
demonstrate high compliance with recommended follow-up
endoscopy."
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
