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Prosigna helps manage patients with early-stage breast cancer by providing an accurate assessment of recurrence risk

The Prosigna Breast Cancer Prognostic Gene Signature Assay 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, to provide a prognostic score indicating the probability of cancer recurrence during the next 10 years for hormone-receptor positive early breast cancer patients.

Prosigna is used to help guide therapeutic decisions so that patients receive therapeutic interventions, such as chemotherapy, only if clinically warranted. The in vitro diagnostic test is indicated in postmenopausal women with hormone receptor-positive, node-negative (Stage I or II) or node-positive (Stage II or IIIA) early-stage breast cancer to be treated with adjuvant endocrine therapy.

Prosigna is indicated for use in postmenopausal women with hormone receptor-positive, node-negative (Stage I or II) or node-positive (Stage II or IIIA) early-stage breast cancer to be treated with adjuvant endocrine therapy.

Prosigna Breast Cancer Prognostic Gene Signature Assay for use on the nCounter® Dx Analysis System is 510(k) cleared and CE-marked for in vitro diagnostic use in the United States and EU, respectively. See Package Insert for details.