Exagen announces publication of two studies of AVISE Lupus
Exagen 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 that are likely to transition to classifiable SLE according to American College of Rheumatology criteria. 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 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 The results showed a statistically significant difference in the physician reported likelihood of SLE in the AVISE Lupus arm compared to the SDLT alone. In addition, for those patients who had a positive AVISE Lupus test result, the physicians were more likely to initiate therapy for SLE, specifically prednisone. The CLASS Clinical Validation study, Complement activation occurs in patients with probable systemic lupus erythematosus and may predict progression to ACR classified SLE, was published in Arthritis & Rheumatology. This second clinical validation study included a total of 246 subjects including 92 probable SLE patients and showed that more pSLE were positive for CB-CAPs or AVISE Lupus than for low complement at the enrollment visit. In pSLE, an AVISE Lupus index value of greater than 0.8 at enrollment predicted fulfillment of a fourth ACR criterion within 18 months.