Prosigna Breast Cancer Prognostic Gene Signature Assay regulatory update

Australia’s Therapeutic Goods Administration ( TGA) 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 with hormone receptor-positive breast cancer. The diagnostic is indicated for lymph node-negative, stage I or II or lymph node-positive, stage II or IIIA breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care. The product is already available in Australia. NanoString said the list price in the U.S. is $2,080, with an equivalent rate in Australia. ...