Exagen Diagnostics has entered into an agreement with non-profit health services company CareFirst BlueCross BlueShield to clinically study its AVISE Lupus test.
Under the terms of the agreement, certain CareFirst members will gain access to the test that is designed to assist in the differential diagnosis of systemic lupus erythematosus (SLE).
SLE is known to be the most common form of lupus, which is an incurable autoimmune rheumatic disease. SLE is considered difficult to detect and currently lacks diagnostic tests.
AVISE Lupus test is a ten-marker diagnostic that comprises cell-bound complement activation products (CB-CAPs) and SLE related markers. It is designed to maximise accuracy and minimise time to diagnosis.
The test and its algorithm have been prospectively validated in clinical trials conducted in a total of more than 1,200 patients. AVISE Lupus is said to have demonstrated better diagnostic accuracy compared to standard biomarkers alone.
The primary objective of the latest study is to evaluate the efficacy and cost-effectiveness of the test in primary care as well as rheumatology settings.
CareFirst plans to use the study findings to ensure maximum benefit to patients while making coverage decisions for AVISE Lupus in the future.
Exagen Diagnostics chief medical officer Arthur Weinstein said: “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.”
As part of the agreement, Exagen and CareFirst will also conduct an exploratory study to investigate the impact of AVISE Lupus test results on primary care physician practice referral patterns.