Studies demonstrate real-world clinical
utility of EsoGuard testing to detect esophageal precancer
NEW
YORK, Dec. 12, 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 that three manuscripts providing
interim results from the Prospective REView of
Esophageal Precancer DetectioN in AT-Risk
Patients (PREVENT) Registry, the CLinical Utility of
EsoGuard (CLUE) study, and full data from the San Antonio
Firefighter study, have been published—the first peer-reviewed
publications demonstrating real-world clinical utility of Lucid's
EsoGuard® Esophageal DNA test to detect esophageal
precancer.
The publications are:
- PREVENT Registries - Englehardt R, Samarasena JB,
Bildzukewicz NA, Hamblin R, Lee VT, deGuzman BJ, Aklog L. (2023).
Real-World Experience and Clinical Utility of EsoGuard®
– Interim Data from the Lucid Registry. J Gastro & Digestive
Systems, 7(2), 43-53. Interim analysis of 409 of 517 enrolled
patients with complete clinical utility data in the PREVENT and
PREVENT-FF registries of patients undergoing EsoGuard testing by
Lucid personnel.
- CLUE Study - Lister D, Fine A, Maheshwari S, Bradley PS,
Lee VT, deGuzman BJ, Verma S, Aklog L. Clinical Utility of
EsoGuard® on Samples Collected with EsoCheck®
as a Triage to Endoscopy for Identification of Barrett's Esophagus
– Interim Data from the CLUE Study. Archives of Clinical and
Biomedical Research, 7 (2023): 626-634. Interim analysis of 220
of 275 enrolled patients with complete clinical utility data in the
prospective, multicenter CLUE study of at-risk patients referred
for EsoGuard testing.
- San Antonio Firefighter Study - Hamblin R, Lee VT,
DeGuzman BJ, Verma S, Aklog L (2023). Clinical Utility of
EsoGuard® as a Barrett's Esophagus Triage Test for
On-duty Firefighters. J Gastrointest Dig Syst 13: 764.
Prospectively collected and retrospectively analyzed clinical
utility data in 391 San Antonio firefighters who underwent EsoGuard
testing at #CheckYourFoodTube Precancer Testing Events.
Collectively, the published studies document near-perfect
concordance between EsoGuard results and the prescribing
physician's decision whether to refer patients for upper endoscopy.
100 percent of EsoGuard-positive patients were referred for
confirmatory upper endoscopy and approximately 98 percent of
EsoGuard-negative patients were not—eliminating the need for
hundreds of costly, invasive, and inconvenient endoscopies. These
results demonstrate that, in real-world use, EsoGuard allows
physicians to appropriately triage at-risk patients, consistent
with established professional society guidelines, and ensure
cost-effective utilization of endoscopy in esophageal precancer
detection.
The CLUE study has completed enrollment and data from the full
cohort of over 500 patients, including data on patient compliance
with referral for endoscopy, will be released and submitted for
publication when patient follow-up and data analysis is complete.
The PREVENT registries are open-ended and have enrolled over 600
patients to date, penetrating even further into the patient
journey, beyond the initial medical decision-making. Additional
publications on the expanded registry cohorts are planned in the
coming months.
"These clinical utility studies, encompassing over 1,000
patients, clearly demonstrate that prescribing physicians are
properly leveraging EsoGuard results to guide their medical
decision making," said Victoria T.
Lee, M.D., Senior Vice President and Chief Medical Officer
of Lucid and PAVmed, who oversees Lucid's clinical research
activities. "EsoGuard allowed physicians to effectively triage
patients at increased risk for esophageal precancer to endoscopy.
We look forward to ongoing expansion of our increasingly robust
EsoGuard clinical utility and validity evidence base."
"The publication of three clinical utility studies, with
excellent results, in peer-reviewed journals, provides us with
critical evidence to expand our ongoing engagement with commercial
payors on medical policy and coverage for EsoGuard," said
Natalie Carfora, Lucid's Vice
President, Market Access of Lucid. "These outstanding clinical
utility results complement existing clinical validity data on
EsoGuard's unprecedented precancer detection performance. This
evidence, coupled with multiple national society guidelines and
consensus statements supporting EsoGuard esophageal precancer
detection, provides us with a strong foundation for our ongoing
market access and reimbursement efforts."
About Lucid Diagnostics
Lucid Diagnostics Inc. is a commercial-stage medical diagnostics
company focused on cancer prevention, 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, is the first and
only commercially available diagnostic test capable of serving as a
widespread screening tool for at-risk patients to mitigate the
risks of cancer and cancer deaths through early detection of
esophageal precancer.
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