NanoString Technologies, Inc., (NASDAQ:NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced that it has received a Class III Medical Device License from Health Canada, clearing the company to market its Prosigna® Breast Cancer Prognostic Gene Signature Assay for assessing a woman's 10-year risk of distant recurrence and accurately identifying the intrinsic biologic subtype of the tumor.
"With Canadian market authorization, which mirrors the CE-marked Prosigna Assay approved for the European Union and Israel, we are enabling clinical labs in Canada to generate critical information to help doctors and their patients make important breast cancer treatment decisions," said Brad Gray, President and Chief Executive Officer of NanoString Technologies. "We will continue to seek regulatory approvals for Prosigna, expanding its availability worldwide and providing greater access to sophisticated genomic tests for patients battling breast cancer regardless of their geographic location."
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 approved by Health Canada 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 Canada.
Canadian research institutes played a critical role in the discovery and development of the PAM50 gene signature, a gene set that serves as the basis for the Prosigna Assay and is used for gene expression based subtyping.
"The Prosigna Assay is the result of a decade of research, in which Canadian researchers have had a major role as co-inventors and leaders in multinational research and development programs," said Torsten Nielsen, M.D., Ph.D., who is a pathologist at the BC Cancer Agency and the Genetic Pathology Evaluation Centre at Vancouver General Hospital. Dr. Nielsen is also co-inventor of the PAM50 gene signature. "I would particularly like to thank my colleagues at the BC Cancer Agency and the NCIC-Clinical Trials Group who have contributed to important research that has demonstrated the value of Prosigna. Health Canada approval means this test can now be considered for Canadian patients battling breast cancer, using local laboratory facilities with clinically certified accuracy."
The Prosigna assay was validated in two clinical studies, including the TransATAC and ABCSG-8 studies, which included more than 2,400 patient samples.
The Prosigna Assay offers key features to molecular technicians and clinicians in Canada, including:
- Identification of intrinsic subtype and individualized estimate of distant recurrence risk.
- All-in-one assay consumables, including RNA extraction kits, 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.
NanoString Technologies, Inc.,