NanoString Technologies, Inc., has been granted 510(k) 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. It uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease and is performed using the nCounterDx Analysis System.
The Prosigna Assay is intended for use as a prognostic indicator for distant recurrence-free survival at 10 years and is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive (one to three positive nodes) hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment consistent with standard of care. For each patient, the Prosigna Assay reports the Prosigna Score (referred to as Risk of Recurrence Score or ROR Score) and a risk category based on both the Prosigna Score and nodal status. Node-negative patients are classified as low, intermediate, or high risk, while node-positive patients are classified as low or high risk.
Other key features include all-in-one assay consumables, including RNA extraction kits; high-throughput workflow, allowing the processing of up to 30 patient samples per eight-hour work day; and automated generation of personalized full-color patient reports.
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 of 2013. Prosigna testing services are expected to be available through qualified U.S. clinical laboratories beginning in the first quarter of 2014. Read a press release about a study that references the Prosigna assay.
