NanoString Receives FDA Clearance For Prosigna Breast Cancer Assay

(RTTNews) - NanoString Technologies, Inc., (NSTG) Monday said it has received clearance from the U.S. Food and Drug Administration, or FDA, for its Prosigna Breast Cancer Prognostic Gene Signature Assay, indicated for finding a patient's risk of distant recurrence of the disease.

The Prosigna Assay can indicate distant recurrence-free survival in postmenopausal women with beginning to advanced stage of breast cancer, at 10 years.

Based on the Prosigna Score and a risk category reported from the Assay, the patients are classified as low, intermediate or high risk. The Prosigna Assay is performed at qualified laboratories throughout the country.

"Prosigna illustrates our approach of using nCounter technology to translate genomic discoveries into powerful in vitro diagnostic products, and it represents a significant growth opportunity beyond our robust life sciences research business," said Brad Gray, President and CEO.

"By integrating the Prosigna Assay into existing laboratory workflows, we are offering physicians and patients seamless and timely access to clinical insights and a powerful tool that can aid in making more informed treatment decisions, " Bruce Seeley, SVP, General Manager, Diagnostics.