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NanoString Gets FDA OK For Gene Signature Assay

Tuesday, September 10, 2013 5:14:00 AM PDT | VentureDeal
   Seattle, Washington  --  NanoString Technologies ( NASDAQ: NSTG) announced that it has received 510(k) marketing clearance from the US Food and Drug Administration for its new gene signature assay.

Prosignia is the company's first FDA-cleared in-vitro diagnostic assay to help assess a patient's risk of distant recurrence of breast cancer.

The assay uses the gene expression profile of cells found in breast cancer tissue for postmenopausal women who have undergone surgery for breast cancer.

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