FDA approves Prosigna assay for Breast Cancer Risk
The FDA has given 510(k) clearance for the Prosigna Breast Cancer Prognostic Gene Signature Assay, from NanoString Technologies. The assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score, to assess a patient's risk of distant recurrence.
The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin-embedded (FFPE) breast tumor tissue. It operates on runs on NanoString's proprietary nCounter Dx Analysis System. Prosigna testing is expected to be available from beginning in the first quarter of 2014. The assay is CE Marked in the EU.
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