Prosigna Breast Cancer Prognostic Gene Signature Assay regulatory update
Health Canada approved NanoString's Prosigna Breast Cancer Prognostic Gene Signature Assay for use as a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women who have undergone surgery in conjunction with locoregional treatment consistent with standard of care. The breast cancer intrinsic subtyping assay is indicated in patients with hormone receptor-positive, lymph node-negative, stage I or II breast cancer or hormone receptor-positive, lymph node-positive, stage II or IIIA breast cancer. NanoString plans to launch Prosigna in Canada by next quarter. The company said the price per test was established last year at $2,080 and that testing services will be priced "similarly" to currently available genomic assays for breast cancer. ...