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Innovative Diagnostic Test for Lupus

Innovative Diagnostic Test for Lupus

Innovative Diagnostic Test for Lupus at West Penn Allegheny Health SystemA new blood test designed by physicians and scientists from West Penn Allegheny Health System to help clinicians diagnose lupus with greater ease and accuracy is now commercially available across the United States.

The Avise-SLE test uses one blood sample from a patient to check for five distinct biomarkers that help to rule-in the diagnosis of systemic lupus erythematosus while ruling out other rheumatic diseases. 

“Lupus has been notoriously difficult to diagnose and frequently misdiagnosed because there was never a specific blood test to administer to patients with suspected lupus,” said Joseph Ahearn, MD, chief scientific officer and vice president, Allegheny-Singer Research Institute (ASRI). “The availability of this test will significantly improve physicians’ ability to reach a definitive diagnosis.”

Dr. Ahearn and Susan Manzi, MD, MPH, co-founders of the Lupus Center of Excellence at WPAHS, began working to develop the test more than a decade ago at the University of Pittsburgh with colleagues Amy Kao, MD, MPH, and Chau-Ching Liu, MD, PhD. The group initiated their work in conjunction with the National Institutes of Health’s Biomarker Definition Working Group.

Dr. Kao subsequently joined WPAHS as director of bioinformatics at the Lupus Center of Excellence and Dr. Liu was recruited by WPAHS to serve as a research scientist with the lupus center and ASRI. A validation study of Avise-SLE was completed last year at WPAHS and a multi-center trial of the panel was conducted at select hospitals across the nation.

The test uses flow cytometry to measure the levels of various proteins or cell-bound complement activation products (CB-CAPs) deposited on the surfaces of all blood cells. Evaluating a combination of CB-CAPs provides results that are more sensitive and specific to lupus diagnosis than the previous gold-standard lupus tests, serum C3 and C4 and anti-double stranded DNA (anti-dsDNA).

In both the multi-center study and a subsequent validation study, Avise-SLE was able to confirm a lupus diagnosis with 78 percent accuracy and rule out other rheumatic diseases with 86 percent accuracy.

“Ruling out a number of diseases that mimic lupus is a crucial part of obtaining the correct diagnosis and assigning the correct treatment,” Dr. Manzi said. “Serious complications of lupus can be prevented or delayed if patients receive early intervention. By ensuring proper, quick diagnosis, we can get patients the best treatment options before major complications, such as organ damage, occur.”

Lupus is a chronic autoimmune disease that causes inflammation and damage to parts of the body, including skin, joints and kidneys. More than 1.5 million Americans have some form of the disease, according to the Lupus Foundation of America.

Avise-SLE is available through Exagen Diagnostics, Inc., a molecular diagnostics laboratory that discovers, develops and markets tests for rheumatologists and gastroenterologists.