Breast cancer prognostic gene-signature assay, 11/13
NanoString Technologies has received FDA 510(k) clearance for its Prosigna breast cancer prognostic gene signature assay. Based on the PAM50 gene signature, Prosigna is the company’s first FDA-cleared in vitro diagnostic assay and uses the gene-expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease. The Prosigna assay is performed using the nCounter Dx analy