Prosigna Breast Cancer Prognostic Gene Signature Assay regulatory update

FDA approved an updated label for NanoString’s Prosigna Breast Cancer Prognostic Gene Signature Assay to include information on the observed risk of distant recurrence in postmenopausal women with estrogen receptor-positive, early stage breast cancer 5-10 years after diagnosis. The diagnostic is used as a prognostic indicator for distant recurrence-free survival at 10 years. It is indicated in postmenopausal women with stage I/II lymph node-negative or stage II lymph node-positive hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment consistent with standard of care. ...