Improved Laboratory Testing with EC4d Can Help Physicians Monitor Patients with Lupus

ALBUQUERQUE, NM and SAN DIEGO, CA, June 12, 2017 -- Exagen Diagnostics, Inc., home of AVISE^® testing, announced the nationwide availability of a new test leveraging the power of cell-bound complement activation products (CB-CAPs) to help physicians monitor patients with Systemic Lupus Erythematosus (SLE). The AVISE SLE Monitor offering is a unique combination of specialized assays that provide valuable insight into SLE disease activity and can be helpful anytime a physician is assessing an SLE patient.

According to board certified rheumatologist Waleed Bolad MD, the management of SLE is much like firefighting, and this new test may very well be a fire alarm to help extinguish disease activity before it manifests as severe and irreversible organ damage. Bolad explains “I will even use this analogy with my patients to help them understand how important it is to pay close attention to their disease symptoms. A small fire in one room is relatively easy to extinguish, but a fire in multiple rooms means the whole house is in jeopardy and will be difficult to fully recover and restore the damage from such a fire. If AVISE SLE Monitor can help us detect one of these small fires, that will be very valuable information indeed.”

AVISE SLE Monitor combines novel tests like EC4d, one of Exagen’s proprietary CB-CAPs assays, with advanced methods like dsDNA by chemiluminescence, both of which have demonstrated significant correlation to disease activity independent of the more common biomarkers C3 and C4 which are also included. ^1-2 Dr. Thierry Dervieux, CSO Exagen Diagnostics, explains, “We have been exploring the relationship between CB-CAPs and disease activity for the past 5 years and expect physicians to find this additional information to be very valuable as they look for clues about an individual’s disease activity. Furthermore, we are including a measurement of anti-C1q autoantibodies which can help assess if a patient is at risk for lupus nephritis, a more severe form of SLE affecting kidney function. When a patient suffering a flare from lupus is successfully managed, they should expect the biomarker levels on AVISE SLE Monitor to reflect that improvement.”

A recent study by Gladman, et al. found that 1 in 4 SLE patients over a 2 year period will present with an indicator of disease activity that is only detectable by laboratory assessment, underscoring the importance of routine lab measures.³ The novel assays and methods in AVISE SLE Monitor are likely to be a welcome adjunct to the ongoing management of patients with SLE. The test has received conditional approval from the New York State Department of Health and is available immediately to physicians throughout the USA.

About AVISE SLE Monitor

AVISE SLE Monitor is an advanced blood test that provides important data to assist physicians anytime they assess the condition of a patient with SLE. This test employs unique state-of-the-art biomarkers with a demonstrated significant correlation with clinical improvements in SLE disease activity, including EC4d which is exclusively available from Exagen.

• Markers in AVISE SLE Monitor include: EC4d, anti-C1q, anti-dsDNA by CIA, C3, and C4.

About Exagen

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

References:

1. Buyon J, et al. Reduction in erythrocyte-bound complement activation products and titers of anti-C1q antibodies associate with clinical improvement in systemic lupus erythematosus. Lupus Science & Medicine 2016;3:e000165
2. Bentow C, et al. International multi-center evaluation of a novel chemiluminescence assay for the detection of anti-dsDNA antibodies. Lupus (2016) 25, 864–872
3. Gladman D, et al. Recommendations for Frequency of Visits to Monitor Systemic Lupus Erythematosus in Asymptomatic Patients: Data from an Observational Cohort Study. J Rheumatol 2013;40;630-633

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

Attachments:

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/f0580a21-01ef-43f7-9cb5-53dbbeae342b

Attachments:

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/8a098a62-6ee6-42c7-b153-5d29d8bc8a70

Brian McEvilly
Exagen Diagnostics, Inc.
858-736-5517
[email protected]