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FDA Updates Labeling for NanoString's Prosigna Test

NEW YORK(GenomeWeb) – NanoString Technologies said after the close of the market on Monday that the US Food and Drug Administration cleared a labeling update for the company's Prosigna Breast Cancer Gene Signature Assay. 

The new FDA labeling provides additional information on the observed risk of distant recurrence five to 10 years after diagnosis, including the identification of low risk node-negative patients who have 1.3 percent probability of distant recurrence between five and 10 years after diagnosis, and the identification of a low-risk portion of node-positive patients who have 3.7 percent probability of distant recurrence between five and 10 years after diagnosis.

NanoString's test was cleared by the FDA in 2013, and the labeling update follows an analysis of data by researchers from the Austrian Breast and Colorectal Cancer Study Group Trial 8, which previously reported that the Prosigna test accurately evaluated the probability of distant recurrence in post-menopausal women with estrogen receptor-positive early stage breast cancer. 

Michael Gnant, a professor at the Medical University of Vienna, said in a statement that "it's essential for the oncology community to identify tools that will accurately differentiate the risk of breast cancer patients to determine who [will] remain at low probability of distant recurrence beyond five years after diagnosis. These data help demonstrate the potential for the Pam50-based Prosigna Assay to inform both the use of adjuvant chemotherapy and the use of extended adjuvant endocrine therapy based on a risk of recurrence score."  

The Scan

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