Acquired genetic alteration IVDs

Intended purpose

The Prosigna Breast Cancer Prognostic Gene Signature Assay is an in vitro diagnostic which uses the gene expression profile of cells found in breast cancer tissue to assess a patient's risk of distant recurrence. The gene expression data are weighted together with clinical variables to generate both a subtype (luminal A, luminal B, Her2-enriched, or basal like) and a score indicative of the probability of distance recurrence of disease. The assay measures the gene expression profile using RNA extracted from Formalin-Fixed, Paraffin-Embedded (FFPE) breast tumor tissue. Veracyte confirm that Veracyte Inc. has the design controls for the device.