The Prosigna Assay is the First Genomic Breast Cancer Diagnostic Test Approved in
"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
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
The Prosigna Assay offers key features to molecular technicians and clinicians in
- 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
The Prosigna assay was clinically validated in two studies, including the TransATAC and ABCSG-8 studies, which included more than 2,400 patient samples.
About the Prosigna Assay and the nCounter Dx Analysis System
The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II or IIIA), HR+ breast cancer. Based on the PAM50 gene signature initially discovered by
The Prosigna Assay requires minimal hands-on time and runs on
The nCounter Dx Analysis System is a highly automated and easy-to-use platform that utilizes a novel digital barcoding chemistry to deliver high-precision multiplexed assays. The system is available in the multi-mode FLEX configuration, which is designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Assay and, when operated in the "Life Sciences" mode, process translational research experiments and multiplexed assays developed by the laboratory.
The Prosigna Breast Cancer Prognostic Gene Signature Assay Intended Use:
a. A prognostic indicator for distant recurrence-free survival at 10 years in post-menopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors.
b. A prognostic indicator for distant recurrence-free survival at 10 years in post-menopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 positive nodes, or 4 or more positive nodes), Stage II or IIIA breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors.
For more information, please visit www.prosigna.com.
For more information, please visit www.nanostring.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the adoption of Prosigna by Australian physicians, patients, and clinical laboratories and our ability to obtain additional regulatory approvals for Prosigna in other countries. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with keeping pace with rapidly changing technology and customer requirements; risks regarding the company's ability to successfully introduce new products; risks that new market opportunities may not develop as quickly as expected; risks associated with competition in marketing and selling products; risks of increased regulatory requirements; risks associated with obtaining reimbursement coverage for Prosigna; as well as the other risks set forth in the company's filings with the
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