This document addresses the proposed use of gene expression profile (GEP) tests to analyze an individual’s genomic information to assist in the risk stratification and clinical management of multiple myeloma. GEP assays examine the messenger RNA (mRNA) patterns of many genes in a tissue sample simultaneously to estimate the underlying activity of cellular biological pathways, including cellular signaling and proliferation.

Position Statement

Investigational and Not Medically Necessary:

Gene expression profile tests are considered investigational and not medically necessary for evaluation or management of multiple myeloma, including but not limited to:

1. Use as a risk stratification tool to predict outcomes in individuals with newly diagnosed multiple myeloma; or
2. Assist in determining the prognosis for survival in individuals with relapsed multiple myeloma.