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NanoString Technologies obtains 510(k) clearance for Prosigna assay

NanoString Technologies, a provider of life science tools for translational research and molecular diagnostic products, has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its Prosigna breast cancer prognostic gene signature assay.

It is reportedly the company’s first FDA-cleared in vitro diagnostic assay to determine the risk of distant recurrence of disease in a patient. Prosigna assay is based on the PAM50 gene signature and is perfomed using nCounter Dx analysis system.

NanoString Technologies president and CEO Brad Gray noted the receipt of FDA 510(k) clearance for Prosigna marks a key milestone for the company and is an important step forward in the treatment of breast cancer.

"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," Gray added.

The Prosigna assay is designed to use as a prognostic indicator for distant recurrence-free survival at ten years. It is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment consistent with standard of care.

The Prosigna-enabled nCounter Dx analysis systems are expected to be available for placement in high-complexity Clinical Laboratory Improvement Amendments (CLIA) certified laboratories late in the fourth quarter 2013.