Exagen Announces Publication of Two Key Studies Validating Clinical Performance of AVISE® Lupus in Patients with Probable SL...
October 15 2019 - 8:15AM
Exagen Inc. (Nasdaq: XGN), an organization dedicated to
transforming the care continuum for patients suffering from
debilitating and chronic autoimmune diseases by enabling timely
differential diagnosis and optimizing therapeutic intervention,
today announced the publication of two key studies. Collectively,
the studies further validate that the information contained in the
AVISE® Lupus test positively impacts physician clinical
decision-making and demonstrated the patented test and algorithm
helped predict those patients with early signs of systemic lupus
erythematous (SLE) that are likely to transition to classifiable
SLE according to American College of Rheumatology (ACR) criteria.
“With these studies, Exagen has documented what many physicians
already know, and that is the AVISE® Lupus test really helps
physicians improve their ability to diagnose and manage patients
suspected of an autoimmune disease,” shared study author Daniel
Wallace MD, FACP, MACR, a board-certified internist and
rheumatologist who serves as Clinical Professor of Medicine at the
David Geffen School of Medicine at UCLA, and Associate Director of
the Rheumatology Fellowship Program at Cedars-Sinai Medical
Center.
The CARE for Lupus Clinical Utility study, a randomized,
prospective, multi-site trial to assess the clinical utility of
multianalyte assay panel with complement activation products for
the diagnosis of SLE, was published in Lupus Science &
Medicine. The prospective study shows results of 145 patients with
a positive anti-nuclear antibody (ANA) test referred to a
Rheumatologist for the suspicion of a connective tissue
disease. Patients were randomized to investigators from 32
academic and community sites which compared the use of the AVISE®
Lupus test to standard diagnosis laboratory testing (SDLT).
The results showed a statistically significant difference
(p<0.05) in the physician reported likelihood of SLE in the
AVISE® Lupus arm compared to the SDLT alone. In addition, for those
patients who had a positive AVISE® Lupus test result, the
physicians were more likely (p=0.034) to initiate therapy for SLE,
specifically prednisone.
The CLASS Clinical Validation study, Complement activation
occurs in patients with probable systemic lupus erythematosus and
may predict progression to ACR classified SLE, was published in
Arthritis & Rheumatology. This second clinical validation study
included a total of 246 subjects including 92 probable SLE (pSLE)
patients and showed that more pSLE were positive for CB-CAPs (28%)
or AVISE® Lupus (40%) than for low complement (9%) at the
enrollment visit (p = 0.0001, for each). In pSLE, an AVISE® Lupus
index value of > 0.8 at enrollment predicted fulfillment of a
fourth ACR criterion within 18 months (hazard ratio = 3.11,
p<0.01).
“We are very pleased with the outcome of these studies and we
are proud to be leading the way with the first-ever clinical
utility studies for novel biomarkers in SLE,” shared Ron Rocca,
President and CEO of Exagen Inc. who added, ”We work very closely
with all stakeholders in today’s healthcare environment and we
understand that our AVISE® Lupus test must meet the needs of each
group in order to be widely adopted. We believe these studies,
combined with our prior evidence, demonstrates that AVISE® Lupus is
clinically validated in both diagnosed and pSLE patients, has
proven clinical utility for providers and their patients, while
providing a net savings to the healthcare system through improved
outcomes and reduced hospital visits.”
About Exagen Inc.
Exagen is dedicated to transforming the care continuum for
patients suffering from debilitating and chronic autoimmune
diseases by enabling timely differential diagnosis and optimizing
therapeutic intervention. Exagen has developed and is
commercializing a portfolio of innovative testing products under
its AVISE® brand, several of which are based on our proprietary
Cell-Bound Complement Activation Products, or CB-CAPs, technology.
Exagen’s goal is to enable rheumatologists to improve care for
patients through the differential diagnosis, prognosis and
monitoring of complex autoimmune and autoimmune-related diseases,
including SLE and rheumatoid arthritis.
Forward-Looking Statements
Exagen cautions you that statements in this press release that
are not a description of historical facts are forward-looking
statements. These statements are based on the Company's current
beliefs and expectations. Such forward-looking statements include,
but are not limited to, statements regarding: the results of these
clinical utility studies validating the AVISE® Lupus test and the
potential to lead to increased adoption of the AVISE® Lupus test;
and the ability of the AVISE® Lupus test to help physicians improve
their ability to diagnose and manage patients suspected of an
autoimmune disease and provide net savings to the healthcare
system. The inclusion of forward-looking statements should
not be regarded as a representation by Exagen that any of its plans
will be achieved. Actual results may differ from those set forth in
this press release due to the risks and uncertainties inherent in
Exagen’s business, including, without limitation: Exagen’s
commercial success depends upon attaining and maintaining
significant market acceptance of its testing products and promoted
therapeutics among rheumatologists, patients, third-party payers
and others in the medical community; if third-party payers do not
provide coverage and adequate reimbursement for Exagen’s testing
products, or they breach, rescind or modify their contracts or
reimbursement policies or delay payments for its testing products
or promoted therapeutics, or if Exagen or its partners are unable
to successfully negotiate payer contracts, Exagen’s commercial
success could be compromised; and other risks described in the
Company’s prior press releases and in the Company’s filings with
the Securities and Exchange Commission, including under the heading
"Risk Factors" in the Company’s Registration Statement on Form S-1
and any subsequent filings with the SEC. You are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof, and we undertake no obligation to
revise or update this press release to reflect events or
circumstances after the date hereof. All forward-looking statements
are qualified in their entirety by this cautionary statement, which
is made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
CONTACTS:
Westwicke Partners Mike
CavanaughMike.Cavanaugh@westwicke.com646.677.1838
Exagen Inc. Brian McEvillybmcevilly@exagen.com760.560.1506
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