NanoString Technologies, a US-based molecular diagnostic products provider, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Prosigna breast cancer prognostic gene signature assay.
PAM50 gene signature-based breast cancer assay is reportedly the company’s first FDA-cleared in vitro diagnostic assay.
Using the gene expression profile of cells found in breast cancer tissue, the assay assesses patient’s risk of distant recurrence of disease.
It is also 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 assay works on nCounter Dx analysis system that can be placed in qualified laboratories throughout the US.
NanoString Technologies president and CEO Brad Gray said: "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."
Other key features include all-in-one assay consumables, RNA extraction kits and high-throughput workflow, which allows each nCounter Dx analysis system to process up to 30 patient samples per eight hour working day, and automated generation of personalised full-colour patient reports that can be quickly and easily shared electronically with ordering oncologists.
NanoString Technologies senior vice-president and general manager of diagnostics Bruce Seeley said: "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."
Prosigna-enabled nCounter Dx analysis systems are expected to be available in the fourth quarter of 2013 for placement in high-complexity Clinical Laboratory Improvement Amendments (CLIA) certified laboratories.
In addition, Prosigna testing services are likely to be available in the first quarter of 2014.
According to GlobalData estimates, the tumour marker market in the US was valued at $489m in 2012 and is expected to grow at a CAGR of 6.6% to reach $765m by 2019.