Prosigna Breast Cancer Prognostic Gene Signature Assay
Assess a patient's risk of distant recurrence of breast cancer
The Prosigna™ Breast Cancer Prognostic Gene Signature Assay (formerly called the PAM50 test) is an in vitro diagnostic assay performed using FFPE breast tumor tissue previously diagnosed as invasive breast carcinoma. This qualitative assay utilizes gene expression data, weighted together with clinical variables to generate a risk category and numerical score, to assess a patient’s risk of distant recurrence of disease.
Indications for testing:
The Prosigna Breast Cancer Prognostic Gene Signature Assay is indicated for use in postmenopausal women with hormone receptor–positive, node-negative or node-positive early-stage (stages I and II) breast cancer to be treated with adjuvant endocrine therapy
Test outputs for risk assessment:
1- Prosigna Score: Derived from a proprietary algorithm based on the PAM50 gene signature, the Prosigna Score is a numerical value on a 0 to 100 scale that correlates with the probability of distant recurrence within 10 years
2- Risk group: Based on the Prosigna Score and nodal status, risk classification is provided to allow interpretation of the Prosigna Score by using cutoffs related to clinical outcome in tested patient populations
Distant recurrence-free survival (DRFS) rates are significantly different among risk groups:
In node-negative patients, the 10-year DRFS rates were >95% for the low-risk group, 90.4% for the intermediate-risk group, and <85% for the high-risk group
In node-positive patients, the 10-year DRFS rates were 94.2% for the low-risk group and 75.8% for the high-risk group.