Exagen Initiates Study to Predict Rheumatoid Arthritis Drug Response (RADR) in Patients with RA
August 04 2022 - 4:06PM
Exagen Inc. (Nasdaq: XGN), a leading provider of
autoimmune testing solutions, announced today the launch of a
prospective clinical study designed to validate a novel and
minimally invasive genomic diagnostic test for rheumatoid arthritis
using the AVISE® RADR platform. The goal of the
Treatment strat
Ification using
Gene
Expression profiling in
Rheumatoid arthritis (TiGER) study is to assess
whether certain biomarkers from synovial biopsies of inflamed joint
tissue accurately predict response to antirheumatic medications.
The TiGER study is the next step in Exagen’s process of bringing
AVISE® RADR to market.
Rheumatoid arthritis is a complex and chronic autoimmune
disease, and can cause not only debilitating joint pain and severe
joint deformities, but damage to internal organs. We believe that
while there are multiple treatment options available, the
appropriate medication for each individual patient is found mostly
through trial and error. Approximately 120,000 Americans are
diagnosed with rheumatoid arthritis every year, with 2 million
patients currently living with the disease. Total rheumatoid
arthritis therapeutic spending in the United States is $30B, with
70-80% of rheumatoid arthritis patients failing to reach low
disease activity, leading to $18B in wasted therapeutic
spending.
“Over the past two decades, the treatment options available to
patients with rheumatoid arthritis have greatly
expanded. However, the quest for biomarkers that would
indicate which medication is most effective for a given patient is
still ongoing. Recent advances in ultrasound technology allow
physicians to biopsy an inflamed joint and obtain synovial tissue
using a minimally invasive technique. I am excited to partner
with Exagen on the TiGER study to identify biomarkers in synovial
tissue for drug response in rheumatoid arthritis, paving the way to
a new age of personalized medicine in the treatment of this
debilitating disease,” said Dr. Ami Ben-Artzi, Principal
Investigator of the TiGER study.
“Most patients who deal with rheumatoid arthritis often need to
try a variety of medications before finding the one that works.
Unfortunately, this process can take a long time. This is not only
costly, but it also means that patients deal with unnecessary pain
and lack of mobility,” said Ron Rocca, President and CEO of Exagen
Inc. “The mission of the TiGER study is to help establish
personalized medicine as the primary form of care in rheumatoid
arthritis.”
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.com760.560.1525
CompanyExagen Inc.Kamal Adawi, Chief Financial
Officerkadawi@exagen.com760.477.5514
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