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The Prosigna™ Breast Cancer Prognostic Gene Signature Assay is a qualitative in vitro diagnostic tool that 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 at 10 years in postmenopausal women with node-negative 

(Stage I or II) or node-positive (Stage II), hormone receptor-positive
(HR+) breast cancer. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin-embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma.

• The only PAM50-based breast cancer genomic signature
• The only genomic breast cancer assay that can be run in your pathology lab
• The only test that is FDA 510(k) cleared for FFPE tissue

 

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