CareFirst and Exagen Diagnostics Announce Evidence Development Agreement for AVISE® Lupus Diagnostic Test

Baltimore, MD (August 20, 2018) - CareFirst BlueCross BlueShield (CareFirst) and Exagen Diagnostics, Inc. (Exagen), a leading Rheumatology specialty life sciences company, today announced an agreement to collaborate to study the impact of Exagen’s proprietary AVISE Lupus test. As part of the agreement, select CareFirst members will have access to the AVISE Lupus test to aid in the differential diagnosis of systemic lupus erythematosus (SLE).

SLE is the most common form of lupus, a complex, incurable autoimmune rheumatic disease. The collaboration is structured to demonstrate the efficacy and cost effectiveness of the test in both a primary care and rheumatology setting. Study results will be used by CareFirst to ensure maximum benefit to the patient when making future coverage decisions for the AVISE Lupus test. The effort is part of CareFirst’s Healthworx program, through which CareFirst works with innovative companies to proactively develop the evidence needed to make new technologies and advances available to its members.

Diagnosing autoimmune diseases, especially SLE, is difficult because signs and symptoms vary considerably from patient to patient. Misdiagnosis can lead to serious consequences including use of inappropriate treatments and irreversible organ damage. Currently, there is no single test to diagnose SLE. AVISE Lupus and its proprietary algorithm has been prospectively validated in clinical trials with over 1,200 patients demonstrating improved diagnostic accuracy compared to traditional biomarkers alone.

“Our Healthworx program is designed to expedite the process through which it can be discerned which promising innovative diagnostic tests, medical devices, digital technologies and treatments should be deployed for the benefit of our members,” said CareFirst Vice President and Chief Medical Officer Daniel Winn, M.D.

Through this collaboration, Exagen and CareFirst will also complete an exploratory study to determine how knowledge of AVISE Lupus results impact primary care physician practice referral patterns. “We are delighted to be working with CareFirst, as we share their interest in seeking to leverage innovation incorporating our novel and proprietary Cell Bound Complement Activation Products (CB-CAPs) for improved health outcomes,” said Exagen CEO Ron Rocca. “This collaboration aims to shorten the time to diagnosis for these patients suffering with a long-term chronic disease.”

Dr. Arthur Weinstein, Chief Medical Officer at Exagen said, “I have worked with CareFirst as a provider for a number of years and am excited to continue to work with CareFirst to advance innovation. This is a unique collaboration which has the potential of ultimately benefitting patients with SLE by enabling earlier diagnosis and consequently earlier and more appropriate treatment.”

About CareFirst BlueCross BlueShield

In its 80th year of service, CareFirst, an independent licensee of the Blue Cross and Blue Shield Association, is a not-for-profit health care company which, through its affiliates and subsidiaries, offers a comprehensive portfolio of health insurance products and administrative services to 3.2 million individuals and groups in Maryland, the District of Columbia and Northern Virginia. In 2016, CareFirst invested nearly $44 million to improve overall health, and increase the accessibility, affordability, safety and quality of health care throughout its market areas. To learn more about CareFirst BlueCross BlueShield, visit our website at or follow us on Facebook, Twitter, YouTube, LinkedIn, Instagram or Google+.

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 diseases (CTD). Its groundbreaking solutions address the full continuum of care with tools designed and clinically shown to help physicians deliver accurate, early diagnosis and optimized therapy. For more information, visit or follow on Facebook, YouTube, LinkedIn or Instagram.

About Exagen’s AVISE Lupus test

AVISE Lupus incorporates biologically-relevant CB-CAPs (Cell-Bound Complement Activation Products) into a proprietary algorithm that yields an index value which is associated with the likelihood for the presence of SLE. 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.