Exagen Releases Largest Comparative Utility Study in Lupus Diagnostics Confirming AVISE® Lupus Delivers Unparalleled Utility

AVISE® Lupus more clinically effective than current standard of care

SAN DIEGO, July 05, 2022 (GLOBE NEWSWIRE) — 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 Relations
Exagen Inc.
Ryan Douglas

Exagen Inc.
Kamal Adawi, Chief Financial Officer

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Source: Exagen Inc.