Exagen’s Proprietary Biomarker Technology Enables Physicians to Make Most Accurate Lupus Diagnosis: Growing Company Making a Big Impact with Patients and Doctors

Contact: Brian McEvilly – bmcevilly@exagen.com

SAN DIEGO, CA — Between 1.5 and 2 million people in the United States have lupus, an autoimmune disease, and according to the Lupus Foundation of America more than 70% of these patients suffer its most severe form: systemic lupus erythematosus, or SLE. Because its symptoms—which include joint and muscle pain, unexplained fevers and fatigue—mimic other ailments, it can be difficult to identify. But delays in diagnosis can be deadly: SLE often causes irreversible damage to organs. Exagen Diagnostics, a rheumatology specialty laboratory with offices in Vista, CA, and Albuquerque, NM, has developed a groundbreaking diagnostic test for lupus that employs proprietary biomarker technology. Marketed as Avise CTD, the diagnostic tool has recently been proven in studies to be a significant improvement over traditional lab tests. It is the only validated lupus test available incorporating scientifically proven CB-CAPS technology, and it is having a big impact with doctors and their patients.

Puja Chitkara, M.D., a rheumatologist in Chula Vista, CA, says, “Avise CTD testing is helping clinicians diagnose the specific rheumatology conditions. It’s very convenient for patients as there is a single blood draw.” Prior to Avise CTD, she says, “we would have to individually order the different autoantibodies and serum complement levels in a commercial lab.” Even after performing that battery of immunological tests, clinicians often experienced a significant number of incorrect diagnoses. A 2004 study in Archives of Internal Medicine, published by the American Medical Association, showed that as many as 51% of patients with suspected autoimmune or immune disorders are initially misdiagnosed, in part because of ambiguous laboratory test results. The authors of the study warned that “misdiagnosis of systemic autoimmune diseases can have serious consequences.”

Exagen and collaborators spent five years validating the Avise CTD test (the name refers to connective tissue disease) and it has been on the market since 2012. Doctors and patients immediately welcomed its speedy and accurate results, and a recent study, published in the on-line journal Lupus Science & Medicine has proven its effectiveness.

“We combined cell-bound complement activation products, or CB-CAPs,” explains Dr. Thierry Dervieux, Exagen’s Chief Scientific Officer and Medical Laboratory Director,“with standard rheumatic disease autoantibodies into a multi-analyte assay with algorithmic analyses, or MAAAs.” The MAAA diagnostics are unique in that they are performed through a single laboratory and yield a single result. “This test is highly specific for SLE,” he says, “approaching 100% in the differentiation of primary fibromyalgia versus SLE.”

In addition to properly identifying lupus, the Avise CTD test has proven valuable for aiding physicians in confirming a diagnosis prior to therapy and in differentiating overlapping disease.

The study results couldn’t come at a better time. May is “Lupus Awareness Month” and polls show that some two thirds of Americans are unfamiliar with the difficult-to-manage disease that affects approximately 5 million people around the world.

Ron Rocca, president and CEO of Exagen, says the company’s groundbreaking diagnostic tools are simply a manifestation of the company’s motto: Patient Focused. Discovery Driven. “The proud men and women of Exagen,” he says, “built this organization to tackle a disorder that is recognized by healthcare providers as one of the most difficult to diagnose. We are committed to helping physicians identify and differentiate lupus from a long list of chameleon-like connective tissue diseases because we fully recognize that without a timely and accurate diagnosis, no pathway to patient care exists.”

About Exagen

Exagen Diagnostics, Inc. is a College of American Pathologists (CAP) and CLIA accredited 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.exagen.com.

About Lupus

Lupus is an autoimmune disease in which the body attacks its own, healthy tissues and organs. Patients with lupus suffer joint and muscle pain, unexplained fevers, hair loss and fatigue, among a number of other puzzling symptoms. A facial rash can appear across the nose and cheeks, though it does not occur in every case. Women are more likely to get it than men, and there’s no definitive cause, though researchers suspect genes may play a role. It’s often triggered by an infection, a particular drug, or even sunlight. There is no cure, though the symptoms can be managed with treatments. For more information, visit www.lupus.org.