Anthem Blue Cross Connecticut LAB.00036 Multiplex Autoantigen Microarray Testing for Systemic Lupus Erythematosus Form

This document addresses multiplex autoantigen microarray testing for the diagnosis and management of systemic lupus erythematosus (SLE), a chronic autoimmune disease. The technology involves simultaneous testing for multiple autoantibodies associated with SLE, and may involve use of a proprietary algorithm to determine a risk score. At least one manufacturer, Exagen, Inc., is marketing such tests in the United States; the SLE-key^® test (ImmunArray) is not currently available. The document does not address panels of individual tests for evaluating SLE.

Position Statement

Investigational and Not Medically Necessary:

Multiplex autoantigen microarray testing to screen for, diagnose, or manage systemic lupus erythematous is considered investigational and not medically necessary.