Exagen Announces Publication of Two Key Studies Validating Clinical Performance of AVISE® Lupus in Patients with Probable SLE and Demonstrating Superior Clinical Utility Compared to Standard Diagnostic Testing

First ever prospective randomized multicenter clinical utility study shows the favorable impact of AVISE® Lupus on clinical decision-making and patient management

SAN DIEGO, Oct. 15, 2019 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), an organization dedicated to transforming the care continuum for patients suffering from debilitating and chronic autoimmune diseases by enabling timely differential diagnosis and optimizing therapeutic intervention, today announced the publication of two key studies. Collectively, the studies further validate that the information contained in the AVISE® Lupus test positively impacts physician clinical decision-making and demonstrated the patented test and algorithm helped predict those patients with early signs of systemic lupus erythematous (SLE) that are likely to transition to classifiable SLE according to American College of Rheumatology (ACR) criteria.

“With these studies, Exagen has documented what many physicians already know, and that is the AVISE® Lupus test really helps physicians improve their ability to diagnose and manage patients suspected of an autoimmune disease,” shared study author Daniel Wallace MD, FACP, MACR, a board-certified internist and rheumatologist who serves as Clinical Professor of Medicine at the David Geffen School of Medicine at UCLA, and Associate Director of the Rheumatology Fellowship Program at Cedars-Sinai Medical Center.

The CARE for Lupus Clinical Utility study, a randomized, prospective, multi-site trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of SLE, was published in Lupus Science & Medicine. The prospective study shows results of 145 patients with a positive anti-nuclear antibody (ANA) test referred to a Rheumatologist for the suspicion of a connective tissue disease.  Patients were randomized to investigators from 32 academic and community sites which compared the use of the AVISE® Lupus test to standard diagnosis laboratory testing (SDLT).  The results showed a statistically significant difference (p 0.8 at enrollment predicted fulfillment of a fourth ACR criterion within 18 months (hazard ratio = 3.11, p