Study documents 100 percent concordance
between EsoGuard® test results and subsequent medical
decision-making
Timely results support recently proposed
federal legislation which seeks to fund guaranteed fire fighter
access to early detection tests such as EsoGuard
NEW
YORK, Sept. 6, 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 data from a retrospective
analysis demonstrating real-world clinical utility of
EsoGuard® Esophageal DNA testing for the detection of
esophageal precancer in a large cohort of fire fighters.
The study documents 100 percent concordance between clinically
directed EsoGuard test results and subsequent medical
decision-making by the prescribing physician. It demonstrates that
EsoGuard can efficiently test large populations at risk for
esophageal precancer, allowing physicians to utilize EsoGuard
results 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 of EsoGuard® as a Triage
Test for Endoscopy to Identify Barrett's Esophagus in Fire
Fighters, has been posted on the leading health sciences
preprint server, medRxiv, pending peer review and publication. The
release of these data closely aligns with and strongly supports
recently proposed federal legislation seeking to fund guaranteed
firefighter access to early detection tests such as EsoGuard.
"The release of these results represents a very important
milestone for Lucid. We can now, for the first time, demonstrate to
payors that physicians are clinically utilizing EsoGuard to
appropriately guide their referral of at-risk patients for
confirmatory endoscopy, namely—that our diagnostic test has
meaningful real-world clinical utility," said Natalie Carfora, Lucid's new Vice President,
Market Access. "Such clinical utility data, along with claims
history, has been a key gating item for us to engage payors to
secure in-network EsoGuard coverage. This retrospective analysis is
the first of four clinical utility studies that we will be
releasing as preprints just prior to submission for peer review and
publication."
"The most direct measure of the clinical utility of any
diagnostic test which returns a positive or negative result, as
EsoGuard does, is whether the prescribing physician uses the binary
test result to make the appropriate medical decision for the
patient. Based on recently updated professional society guidelines,
the appropriate decision following an EsoGuard result is clearcut.
Patients with positive results should be referred for confirmatory
endoscopy and those with negative results should not undergo
endoscopy unless another indication emerges," Ms. Carfora
added.
The manuscript reports on prospectively collected and
retrospectively analyzed clinical utility data from Lucid's first
#CheckYourFoodTube Precancer Testing Event held earlier this year
in partnership with the San
Antonio Fire Department (SAFD). 391 SAFD fire fighters
who were deemed by a physician to be at-risk for esophageal
precancer participated in the event. A Lucid clinician performed
successful nonendoscopic esophageal cell sampling using Lucid's
EsoCheck® Cell Collection Device in 388 fire fighters—a
99 percent technical success rate. The 372 samples with sufficient
DNA (97 percent) underwent EsoGuard testing at Lucid's
CLIA-certified, CAP-accredited molecular diagnostic laboratory
in Lake Forest, California.
The prescribing physician referred all of the 28 fire fighters with
positive EsoGuard results (7 percent) to a gastroenterologist for
confirmatory endoscopy and referred none of the firefighters with
negative EsoGuard results for endoscopy. This represents 100
percent concordance between EsoGuard test results and subsequent
physician medical decision-making. By providing the prescribing
physician with binary EsoGuard results and enabling triage of only
EsoGuard-positive patients to endoscopy, EsoGuard eliminated the
need for hundreds of costly, invasive, and inconvenient endoscopy
procedures, while remaining consistent with screening
recommendations from professional society guidelines.
"These outstanding results of our first clinical utility study
could not be more timely," said Lishan
Aklog, M.D., Lucid's Chairman & Chief Executive Officer.
"We have been gearing up to fully engage with payors for some time
and are now armed with excellent clinical utility data and an
expanding claims history to support these engagements. The timing
aligns with our recent transition to an upgraded revenue cycle
management provider, which continues to have a positive impact on
claims processing, allowances, and collections. It also aligns with
the addition of Natalie Carfora as
our new VP of Market Access. Ms. Carfora brings a proven track
record of successful payor engagement with both private and
government insurers, and a highly creative and strategic approach,
including a variety of pilot programs with payors and self-insured
entities, and utilizing clinical utility studies to drive larger
coverage policies."
"The release of these results also aligns with the recent flurry
of attention cancer prevention in fire fighters has garnered as a
result of recently proposed federal legislation which seeks to fund
guaranteed fire fighter access to early detection tests such as
EsoGuard," Dr. Aklog added. "The epidemiologic data driving this
attention is overwhelming and unequivocal. Fire fighters have a
substantially increased occupational risk of many different types
of cancer, but their relative risk of esophageal cancer (162
percent) and esophageal cancer death (138 percent) is second only
to mesothelioma, for which no early detection test is currently
available. Although blood-based multi-cancer early detection
(MCED) tests have the potential to offer early detection of
multiple cancers in firefighters and others, it simply cannot do so
for esophageal cancer. Not only is MCED's published sensitivity in
early-stage esophageal cancer poor, but it is also well established
that the high mortality in Stage I esophageal cancer mandates
early precancer detection. EsoGuard provides an
unprecedented precancer sensitivity of over 80 percent, while no
other single or multi-cancer early detection test, blood-based or
otherwise, provides any sensitivity in detecting
esophageal precancer."
This summer, Congressman Josh
Gottheimer (NJ-5) introduced the
bipartisan Firefighter Investments to
Recognize Exposure to Cancer Act
("FIRE Cancer Act") in the U.S. House of Representatives,
garnering widespread stakeholder support through endorsements by
the New Jersey Firefighters Mutual Benevolent Association, the
International Association of Fire Fighters, the
Professional Firefighters Association of New Jersey, the New Jersey
State Firemen's Association, and the National Association of
Government Employees. The FIRE Cancer Act seeks to amend the
Federal Fire Prevention and Control Act of 1974 to "make
available under the assistance to firefighters grant program the
establishment of cancer prevention programs…" and, more
specifically, "to establish cancer prevention programs for
firefighting personnel, including providing multi-cancer early
detection testing or other forms of preventative tests…to be
appropriated $700,000,000 for
grants."
"Last month, I had the pleasure of traveling to DC to meet with
Congressman Gottheimer's deputy chief of staff and legislative
director to discuss the bill and the critical role EsoGuard will
play in fulfilling the bill's mission to prevent the cancers which
fire fighters disproportionately suffer from as a direct result of
their heroic work. I applauded Congressman Gottheimer and his
co-sponsor, Congressman Anthony D'Esposito (NY-4), for leading this
critically important bipartisan effort and committed to doing our
part to ensure the legislation becomes law so that these at-risk
brave men and women have guaranteed access to the early detection
tests they deserve," Dr. Aklog concluded.
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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