Serum Biomarker Panel Testing for Systemic Lupus Erythematosus and Other Connective Tissue Diseases

This policy covers serum biomarker panel testing to aid diagnosis and differentiation of systemic lupus erythematosus (SLE) and other connective tissue diseases (CTDs) in patients with signs/symptoms suggestive of SLE, equivocal or indeterminate ANA results, suspected antiphospholipid syndrome, inflammatory myopathies, or other CTD differential diagnoses. Major limitations: proprietary panel tests and index-score algorithms (e.g., Avise LDTs) are considered experimental/investigational and not covered, testing is limited to CLIA high‑complexity labs, and selected results (eg, anti‑dsDNA) require confirmatory assays while interpretation must account for established serologic and classification criteria limitations.

"Predominantly affects women between ages 15 and 44 years"

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