Prosigna Test
Definition
Prosigna is an FDA-approved breast cancer recurrence risk test based on the PAM50 gene expression signature; it combines a 50-gene expression profile with clinicopathological factors (such as tumor size) to determine the 10-year distant recurrence risk and molecular subtype (Luminal A/B, HER2-enriched, basal-like) in early-stage, hormone receptor-positive breast cancer. The result is used to support the adjuvant chemotherapy decision and can be run in a local pathology laboratory on formalin-fixed tissue.
Method
Gene expression
Accepted sample types
Solid Tumor, FFPE
Description
The Prosigna test provides information about breast cancer prognosis based on the expression of 50 different genes. It provides information about the risk of disease recurrence over a 10-year period based on tumor size and nodal status, and classifies patients into three risk categories: low, intermediate, and high.
Inheritance
Measures the gene expression profile (somatic/tumor-specific transcriptional signature) in tumor tissue; it is not a germline mutation analysis.