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NanoString Technologies Inc Receives FDA 510 Clearance for Prosigna Breast Cancer Prognostic Gene Signature Assay

Monday, 9 Sep 2013 04:10pm EDT 

NanoString Technologies Inc announced that it has received 510 clearance from the U.S. Food and Drug Administration (FDA) 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 Analysis System, which can be placed in qualified laboratories throughout the United States, empowering oncologists and pathologists to quickly and easily meet the testing needs of their breast cancer patients. 

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0.49 +3.91%
26 Jan 2015