Benzinga | Jul 13, 2021 04:11PM EDT

Exagen Announces AVISE Lupus Test Demonstrates Statistically Significant Clinical Utility in Achieving a Definitive SLE Diagnosis and Positively Impacts Treatment Decisions

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."