NEW YORK (GenomeWeb News) – NanoString Technologies said after the close of the market Monday that the US Food and Drug Administration has granted 510(k) clearance of the firm's Prosigna Breast Cancer Prognostic Gene Signature Assay.

The assay is based on the PAM50 gene signature and analyzes the gene expression profile of cells found in breast cancer tissue to assess a patient's risk of distant recurrence of disease. Prosigna is NanoString's first FDA-cleared product and runs on the firm's nCounter Dx Analysis System.

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