Prosigna Breast Cancer Assay
Use
The Prosigna Breast Cancer Assay is a genomic test that provides prognostic information to help physicians and breast cancer patients make informed treatment decisions. It is designed for post-menopausal patients with early-stage hormone-receptor positive and HER2-negative breast cancer. The assay helps determine the risk of cancer recurrence within the next 10 years when only anti-hormonal treatment is administered.
Special Instructions
The Prosigna test is included in leading international clinical guidelines and is used following breast cancer surgery to aid in treatment planning. It may influence the decision regarding the addition of chemotherapy to hormone therapy based on the risk score provided.
Limitations
The test is specifically indicated for hormone-receptor positive, HER2-negative breast cancer in post-menopausal women and may not be applicable to other breast cancer subtypes or male breast cancer. The risk scores and categories provided are based on genomic analysis of a 50-gene signature and should be interpreted in conjunction with clinical data. It does not predict response to specific chemotherapeutic agents.
FDA Approved
Methodology
NGS
Biomarkers
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided