New Study Reveals Valuable New Markers in the Management of Systemic Lupus Erythematosus

Contact: Brian McEvilly – bmcevilly@exagen.com

SAN DIEGO, CA and Albuquerque, NM – New evidence supports the role of Exagen’s proprietary blood test in monitoring patients with Systemic Lupus Erythematosus (SLE). Three world-renown lupus centers collaborated to reveal significant association between clinical disease activity and levels of the patented biomarker Erythrocyte-bound C4d (EC4d).

SLE is known as the great masquerader and, as this name implies, it is not only challenging to diagnose, it is hard to know when the disease is truly under control.

This new study by Merrill J, et al., published in Lupus Science & Medicine, explores the added information provided by novel blood-based markers in monitoring SLE disease activity. The conclusion is that the EC4d, anti-C1q, and a special method of measuring dsDNA all show significant associations with disease activity. The combination of these novel blood tests with the current standard of care markers C3 and C4 is exactly what providers can now receive when ordering the AVISE® SLE Monitor test from Exagen. The availability of this lab test provides physicians new insight that may help improve management of SLE.

Dr. Arthur Weinstein, Exagen’s Chief Medical Officer explained, ”any disease that can flare and then spontaneously remit is admittedly the most difficult to manage for care providers.” He added, ”in reality, many community based rheumatologists are not measuring SELENA-SLEDAI, a validated disease activity measure, so they rely on C3/C4 and dsDNA to reveal activity not apparent by clinical observation, and that simply is not sensitive enough. Getting a more complete picture of underlying disease activation with these specialized markers in AVISE SLE Monitor may be the only laboratory evidence that a patient is responding to therapy, or conversely that a current treatment is not controlling the disease.”

“It was a real pleasure to collaborate with this prestigious group of authors,” commented Dr. Thierry Dervieux, Chief Scientific Officer at Exagen. “We are especially encouraged by the data showing that our unique markers correlated with disease activity measures across a broad range of disease severity, suggesting all SLE patients can potentially benefit from the additional insightgained by the AVISE SLE Monitor test.

Lupus is an autoimmune disease in which the body attacks its own healthy tissues and organs. Patients with lupus suffer a puzzling array of symptoms ranging from relatively benign rashes and oral sores, to life threatening cardiac and liver complications. Women are more likely to get it than men, and there’s no definitive cause nor cure, though there are therapy options that focus on reducing the symptoms and minimizing permanent damage to organs. Patients who achieve disease control of remission can often live normal productive lives however disease flares take their toll causing significant morbidity and disability.

About AVISE SLE Monitor

AVISE SLE Monitor is a combination of five advanced tests that provides important data to assist physicians anytime they assess the status of a patient with SLE. This test employs erythrocyte bound C4d (EC4d) along with other key markers which have demonstrated significant correlation to SLE disease activity. AVISE SLEMonitor gives the treating care provider an accurate glimpse into the serologic measures of disease activity allowing for a more complete picture of how well a patient’s condition is being managed.

About systemic lupus erythematosus (SLE)

Systemic lupus erythematosus (SLE) is the most common form of lupus, affecting approximately 70 percent of an estimated 5 million people with lupus worldwide. It is a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body.

Patients with SLE are at risk of irreversible organ damage, which can accrue over time and which can lead to kidney transplants and even death. This prognosis makes the timely and accurate diagnosis of SLE and appropriate management thereafter extremely critical. Improved time to diagnosis and management of the disease can also help reduce healthcare utilization costs for patients with SLE.

About Cell-Bound Complement Activation Products (CB-CAPs)

CB-CAPs (EC4d & BC4d) are stable biomarkers of complement activation. Exagen measures deposits resulting from activation of the complement system using flow cytometry to quantify C4d which is covalently bound to circulating cells including erythrocytes and B cells.

About Exagen

Exagen Diagnostics, Inc. is a College of American Pathologists (CAP) accredited and CLIA certified specialty laboratory focused on the significant unmet need for accurate and timely diagnosis, prognosis and monitoring of autoimmune connective tissue diseases (CTD). Its groundbreaking solutions address the full continuum of care to help physicians deliver accurate, early diagnosis and optimized therapy. For more information, visit www.exagen.com or follow us on Facebook, Twitter, YouTube, LinkedIn, or Instagram.

Exagen, AVISE, and the Exagen and AVISE logos are registered trademarks of Exagen Diagnostics.

US Media Inquiries:
Brian McEvilly
Exagen Diagnostics, Inc.