NEW YORK (GenomeWeb) – NanoString Technologies said after the close of the market Tuesday that Canadian regulatory authorities have cleared the firm's Prosigna Breast Cancer Prognostic Gene Signature Assay for marketing.
The Class III Medical Device License from Health Canada clears the Prosigna assay for assessing a woman's 10-year risk of distant recurrence of breast cancer and accurately identifying the intrinsic biologic subtype of the tumor.
The Prosigna assay runs on NanoString's nCounter Dx Analysis System. It is based on the PAM50 gene signature and assesses the gene expression profile of cells found in a woman's breast cancer tissue.
Prosigna received US Food and Drug Administration clearance in September 2013 as a prognostic indicator for distant recurrence-free survival at 10 years. In the US it is indicated for 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.
"With Canadian market authorization, which mirrors the CE-marked Prosigna Assay approved for the European Union and Israel, we are enabling clinical labs in Canada to generate critical information to help doctors and their patients make important breast cancer treatment decisions," NanoString President and CEO Brad Gray said in a statement.