Exagen Releases Largest Comparative Utility Study in Lupus Diagnostics Confirming AVISE® Lupus Delivers Unparalleled Utility
July 05 2022 - 8:25AM
Exagen Inc. (Nasdaq: XGN), a leading provider of
autoimmune testing solutions, announced new robust, real-world
evidence confirming AVISE® testing enables decisive clinical action
in the differential diagnosis for lupus. The Complement Activation
Products vs. Standard ANA Testing: Treatment Outcomes, Diagnosis,
and Economic Impact in Systemic Lupus Erythematosus (CAPSTONE)
study is the largest comparative utility study in lupus diagnosis
and was published in the Journal of Managed Care & Specialty
Pharmacy. The study leveraged multiple external databases
encompassing electronic health records and linked insurance claims
data on nearly 50,000 patient tests with AVISE or standard of care
labs from hundreds of rheumatologists across the U.S., comparing
diagnosis, treatment, and cost of care outcomes for new patients
tested with AVISE Lupus and those tested with a traditional ANA
(tANA) approach, including specific autoantibodies. The findings
revealed that the AVISE Lupus test is more clinically effective,
both for patients who test positive and those who test negative, as
compared to the current standard of care.
Key findings include:
- 2x decrease in diagnostic testing
costs in the first six-month follow-up period for AVISE Lupus [-]
vs tANA[-]
- 3.5x less frequent repeat testing
overall when using AVISE Lupus vs tANA
- 6x increased odds of establishing a
new SLE diagnosis with AVISE Lupus [+] vs tANA[+]
- 3x increased odds of initiating one
or more SLE treatments with AVISE Lupus [+] vs tANA[+]
“The results of our study are incredible. For either a positive
or negative test result, patients receive the most clinically
effective information from the AVISE Lupus test. This benefits the
patient, the provider, and the payor. We are incredibly proud of
the AVISE Lupus test and are thrilled to be able to show these
real-world results,” said Ron Rocca, Exagen’s President and Chief
Executive Officer.
The study clearly establishes the superiority of the AVISE Lupus
test for patients, providers and payors. Delayed diagnosis leads to
increased disease burden and diminished quality of life for the
patient. By receiving conclusive results, providers were able to
initiate treatment early, reducing the need for more aggressive
approaches down the road that can lead to irreversible consequences
for the patient. Additionally, a conclusive negative test allowed
providers to lower the number of repeat tests and follow-up visits
which is a critical step for achieving diagnostic clarity for the
patient.
The study can be found here.
About Exagen Inc.
Exagen (Nasdaq: XGN) is a leading provider of autoimmune
diagnostic, prognostic, and monitoring testing
solutions. Exagen is a patient focused, discovery driven
organization built on the success of AVISE testing and is investing
in its product pipeline to support patients throughout their
autoimmune diagnosis and treatment journeys. The goal at Exagen is
to assist patients, physicians, and payors by enabling precision
medicine. Exagen is located in San Diego
County with clinical and research and development laboratories
in Vista, CA.
For more information, please visit Exagen.com and
follow @ExagenInc on Twitter.
Forward Looking Statements
Exagen cautions you that statements contained in this press
release regarding matters that are not 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 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 its business, financial condition and
results of operations, including as a result of slowdown in its
operations as well as those of its 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 its tests causing an increase in cost per
test, its sales and commercialization activities and its ability to
receive specimens and perform or deliver the results from its
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 its tests; Exagen’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;
Exagen’s ability to successfully execute on its business
strategies; third party payors not providing coverage and adequate
reimbursement for Exagen’s testing products or promoted
therapeutics, including Exagen’s ability to collect funds due;
expectations regarding its pipeline products, including the
development of the AVISE RADR platform; Exagen’s ability to obtain
and maintain intellectual property protection for its testing
products; regulatory developments affecting Exagen’s business; and
other risks described in Exagen’s prior press releases and Exagen’s
filings with the Securities and Exchange Commission (“SEC”),
including under the heading “Risk Factors” in Exagen’s Annual
Report on Form 10-K for the year ended December 31, 2021 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.com 760.477.5514
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