SAN DIEGO, CA--(Marketwired - November 21, 2016) - Exagen Diagnostics announced today another peer-reviewed journal publication featuring the excellent performance of the AVISE® Lupus test. The article entitled: "The AVISE Lupus Test and Cell-bound Complement Activation Products Aid the Diagnosis of Systemic Lupus Erythematosus" uncovers the agreement between the results of the proprietary AVISE test and the physician's diagnosis.
Published in The Open Rheumatology Journal, the results of this retrospective case review study demonstrated an 83% sensitivity and 86% specificity for detection of SLE according to the physician's clinical diagnosis.
Dr. Thierry Dervieux, Exagen's Chief Scientific officer, shared: "It is really quite impressive that the real-world performance of this test meets, and even exceeds, the results demonstrated across multiple validation sets. Exagen has always investigated the performance of the test in situations where the differential diagnosis is very challenging. Most trained clinicians can readily distinguish healthy individuals from those suffering active Systemic Lupus Erythematosus (SLE), however, even the most savvy physician will admit to needing better serologic markers when faced with overlapping symptoms and a host of probable disease states."
According to Dr. James Mossell, the publications lead author: "Throughout the rheumatology community, people are starting to take notice that these novel Cell-Bound Complement Activation Products (CB-CAPs), combined with a powerful algorithm, are instrumental in identifying patients with immune-mediated disease. A delayed diagnosis, or inappropriate therapy can cause irreversible organ damage so the stakes are high."
Before the test was available, a research study indicated that patients where inaccurately diagnosed with SLE 47% of the time by non-specialists and 27% of the time by specialists. Having access to an advanced test like AVISE should significantly improve upon those figures.
"ANA positive referrals make up a large proportion of patients sent to a specialist for diagnosis of a suspected autoimmune disease", says Ron Rocca, CEO and Chairman of the Board at Exagen Diagnostics. "We are pleased to see that this important study further illustrates how our test helps accurately diagnose patients even when the standard of care classification criteria are inconclusive."
Exagen Diagnostics, Inc. is a College of American Pathologists (CAP) accredited and CLIA certified rheumatology specialty laboratory that focuses on the significant unmet need for accurate and timely diagnosis, prognosis and monitoring of autoimmune connective tissue disease (CTD). Its groundbreaking solutions address the full continuum of care with tools designed and scientifically proven to help physicians deliver accurate, early diagnosis and optimized therapy. For more information, visit www.avisetest.com.
About Lupus and Rheumatoid Arthritis
Lupus and rheumatoid arthritis are autoimmune diseases in which the body's defense mechanisms mistakenly attack its own healthy tissues and organs. Patients suffer joint pain along with increased risk for other life threatening conditions. Systemic Lupus Erythematosus (SLE), a more severe form of lupus brings with it a host of unwanted symptoms including unexplained fevers, hair loss, fatigue, and skin rashes. Women are more likely to suffer from these conditions vs. men, and there's no definitive cause nor cure.