CareFirst and Exagen Teaming Up to Investigate Impact of AVISE Lupus Diagnostic Test

Joana Carvalho, PhD avatar

by Joana Carvalho, PhD |

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CareFirst BlueCross BlueShield and Exagen Diagnostics are collaborating on a study to assess the impact of the AVISE Lupus test, Exagen’s diagnostic test for systemic lupus erythematosus (SLE).

“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 benefiting patients with SLE by enabling earlier diagnosis and consequently earlier and more appropriate treatment,” Arthur Weinstein, MD, chief medical officer at Exagen, said in a press release

SLE, the most common form of lupus, is a chronic rheumatic autoimmune disease whose symptoms vary considerably from patient to patient, often leading to a delay in diagnosis or even a complete misdiagnosis. There is no single clinical test to diagnose SLE yet.

AVISE Lupus is a diagnostic test based on 10 different SLE biomarkers. According to Exagen, which focuses on developing diagnostics for autoimmune connective tissue diseases, it has greater sensitivity and specificity than other SLE diagnostic tests.

The test has already been validated in prospective clinical trials with more than 1,200 participants and showed higher accuracy than traditional biomarkers alone.

Under the new agreement, some CareFirst members will have access to the test to assist with lupus diagnosis. The collaboration is aimed at proving the efficacy and cost effectiveness of the AVISE Lupus test in primary care and rheumatology clinical units.

CareFirst, a nonprofit health insurance company, is planning to use the information gained from the study to assist in coverage decisions for patients for the AVISE Lupus test.

This initiative is part of CareFirst’s Healthworx program, through which it collaborates with other companies to obtain the necessary evidence to make new products available to its members.

“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 Daniel Winn, MD, CareFirst’s vice president and chief medical officer.

In addition, CareFirst and Exagen are planning to conduct an exploratory study to determine how knowledge of the AVISE Lupus test could affect referral patterns of primary care physicians in a clinical setting.

“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 Ron Rocca, Exagen’s CEO. “This collaboration aims to shorten the time to diagnosis for these patients suffering with a long-term chronic disease.”