NanoString Technologies has received market approval from the Australian Therapeutic Goods Administration (TGA), clearing the company to market its Prosigna breast cancer prognostic gene signature assay for assessing a woman’s risk of distant recurrence of disease.
The Prosigna assay was launched in the U.S. in December 2013 and is also CE Marked for in vitro diagnostic use in the European Union and Israel, and is licensed for use in Canada.
"The Prosigna Assay continues to gain support in the U.S. and internationally as regulatory bodies recognize Prosigna’s strong clinical and analytical validation," said Brad Gray, President and Chief Executive Officer of NanoString Technologies. "With Australian market authorization, which mirrors the CE-marked Prosigna Assay for the European Union and Israel, we are enabling clinical labs in Australia to generate critical information to help doctors and their patients make important breast cancer treatment decisions."
Prosigna is an in vitro diagnostic breast cancer assay run on the nCounter® Dx Analysis System that assesses the gene expression profile of cells found in a woman’s breast cancer tissue. This information is then used to identify intrinsic subtype of the tumor and assess the risk of distant recurrence of disease in postmenopausal women with hormone receptor-positive (HR+) early-stage breast cancer. The Prosigna Assay is the first diagnostic test for breast cancer approved by TGA for use in local, qualified clinical laboratories, enabling oncologists and pathologists to meet the diagnostic needs of patients with breast cancer without sending tissue samples outside of Australia.
The Prosigna Assay offers key features to molecular technicians and clinicians in Australia, including:
• Identification of intrinsic subtype and individualized estimate of distant recurrence risk.
• All-in-one assay consumables, allowing laboratories to test as little as a single section of formalin-fixed paraffin embedded (FFPE) tumor tissue.
• High-throughput workflow allowing each nCounter Dx Analysis System to process up to 30 patient samples per eight hour work day.
"Expanding global availability of Prosigna is an important part of our long-term growth strategy for this breast cancer diagnostic," said Bruce Seeley, Senior Vice President and General Manager of Diagnostics at NanoString Technologies. "By simplifying and decentralizing genomic testing, we believe the Prosigna Assay will provide physicians worldwide with more important clinical information while ensuring broader patient access. Most importantly, breast cancer patients in Australia will now have access to an innovative new genomic test that can be performed locally."
The Prosigna assay was clinically validated in two studies, including the TransATAC and ABCSG-8 studies, which included more than 2,400 patient samples.
