Exagen Initiates Study to Predict Rheumatoid Arthritis Drug Response (RADR) in Patients with RA
TIGER study to assess whether certain biomarkers from synovial biopsies of inflamed joint tissue accurately predict response to antirheumatic medications
SAN DIEGO, Aug. 04, 2022 (GLOBE NEWSWIRE) — 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 stratIfication 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.
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.
Kamal Adawi, Chief Financial Officer