TEST:

Prosigna™ Breast Cancer Prognostic Gene Signature Assay

The Prosigna Breast Cancer Prognostic Gene Signature Assay (formerly called the PAM50 test) uses advanced genomic technology to inform next steps for patients with early-stage breast cancer, based on the genomic make-up of their disease. The test analyzes the activity of 50 genes known as the PAM50 gene signature, along with clinical-pathological features, and can provide a hormone-receptor positive early breast cancer patient and her physician with a prognostic score indicating the probability of cancer recurrence during the next 10 years. Outside of the United States, it is also utilized to provide PAM50 molecular subtype information. The Prosigna test is FDA 510(k) cleared in the United States for use on the nCounter® Dx Analysis System