The Prosigna Assay on the nCounter Dx Analysis System Provides
Compelling Clinical Data, Clear Patient Report, and Localized Processing
"With Canadian market authorization, which mirrors the CE-marked
Prosigna Assay approved for the
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
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
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
- 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.
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), 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 postmenopausal women with 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 postmenopausal women with 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 Canadian
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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