AVISE® Lupus Test Demonstrates Statistically Significant Clinical Utility in Achieving a Definitive SLE Diagnosis and Positi...
July 13 2021 - 4:05PM
Exagen Inc. (Nasdaq: XGN), a leading provider of
autoimmune testing solutions, announced today the publication of
their latest clinical utility study in Lupus & Science
Medicine, found here:
https://lupus.bmj.com/content/8/1/e000528.full. This multi-center
study demonstrated that the AVISE Lupus test helped increase
confidence in ruling-in and ruling-out systemic lupus erythematosus
(SLE) in patients suspected of this disease and informed
appropriate treatment decisions.
In collaboration with 12 rheumatology practices, a systematic
and longitudinal review of medical records of patients that
received AVISE testing between 2018 and 2020 was performed. Medical
records of antinuclear antibody (ANA)-positive patients with a
positive or negative AVISE Lupus score were evaluated at three time
points: when the test was ordered, when the test results were
reviewed, and at least 8 months later.
Assessment of the confidence in the diagnosis of SLE and
initiation of hydroxychloroquine (HCQ) showed that the AVISE Lupus
test impacted physician behavior. In particular, physician
certainty in an SLE diagnosis increased with increasing AVISE Lupus
scores. Similarly, certainty in an SLE diagnosis decreased when an
AVISE Lupus score was negative, indicating that the test helped in
both ruling-in and in ruling-out the disease. AVISE Lupus also
helped make an accurate diagnosis, both early on and during the
course of the study, and higher AVISE Lupus scores led to an
increased initiation of HCQ treatment, demonstrating the potential
utility of the test in impacting patient management by informing
appropriate treatment decisions.
Exagen President and CEO, Ron Rocca, shared, “We are thrilled to
share the publication of another great study demonstrating the
clinical utility of our AVISE testing. With patients at the
forefront of our minds, we will continue to support rheumatologists
in the diagnosis of SLE and other debilitating autoimmune diseases
for their patients.”
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 providers to improve care for patients
through the differential diagnosis, prognosis, and monitoring of
complex autoimmune and autoimmune-related diseases, including
rheumatoid arthritis and lupus. For further information please
visit www.exagen.com.
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 Exagen's current beliefs
and expectations. Such forward-looking statements include, but are
not limited to, statements about Exagen’s goals and strategies,
regarding the potential utility and effectiveness of Exagen’s
services and testing solutions and regarding Exagen’s
interpretation of clinical study results and management’s views and
evaluations of the same. 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: the COVID-19 pandemic may continue to adversely affect
our business, financial condition and results of operations,
including as a result of shutdowns of our facilities and operations
as well as those of our suppliers and courier services, impeding
patient movement and interruptions to healthcare services causing a
decrease in test volumes, disruptions to the supply chain of
material needed for our tests, our sales and commercialization
activities and our ability to receive specimens and perform or
deliver the results from our tests, delays in reimbursement and
coverage decisions from Medicare and third-party payors and in
interactions with regulatory authorities, and delays in ongoing and
planned clinical trials involving our tests; the company’s
commercial success depends upon attaining and maintaining
significant market acceptance of its testing products and promoted
therapeutics among rheumatologists, patients, third-party payors
and others in the medical community; the company’s ability to
successfully execute on its Dx/Rx strategy; third party payors not
providing coverage and adequate reimbursement for the company’s
testing products or promoted therapeutics; the company’s ability to
obtain and maintain intellectual property protection for its
testing products; regulatory developments affecting the company’s
business; and other risks described in the company’s prior press
releases and the Exagen’s filings with the Securities and Exchange
Commission (SEC), including under the heading “Risk Factors” in the
company’s Annual Report on Form 10-K for the year ended December
31, 2020 on 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 Exagen
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist 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.
Investor RelationsExagen Inc.Ryan
Douglasrdouglas@exagen.com 760.560.1525
CompanyExagen Inc.Kamal Adawi, Chief Financial
Officerkadawi@exagen.com760.477.5514
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