Multi-Mode System Available for Running the Prosigna Breast Cancer
Other Multiplexed Research Assays, and Laboratory Developed Tests
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 nCounter Dx Analysis System supports the Prosigna Breast Cancer Prognostic Gene Signature Assay, an in vitro diagnostic assay that uses the gene expression profile of cells found in breast cancer tissue to assess a patient's risk of distant recurrence of disease. Using the nCounter Dx Analysis System, the Prosigna Assay can be performed in qualified clinical laboratories throughout the U.S. and countries that accept the CE Mark, empowering oncologists and pathologists to quickly and easily meet the testing needs of their breast cancer patients for determining the risk of distant disease recurrence.
The nCounter Dx Analysis 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 Breast Cancer Assay and, when operated in the "Life
Sciences" mode, process translational research experiments and
multiplexed assays developed by the clinical laboratory. The nCounter
Elements™ General Purpose Reagents (GPRs) offered by
"We have received significant interest from laboratories seeking to
perform the Prosigna Breast Cancer Assay as well as run genomic assays
that they have developed independently," said
"We're excited to be the first laboratory in the U.S. to adopt the
nCounter Dx Analysis System," said Dr.
When used together, the nCounter Dx Analysis System and Prosigna Breast Cancer Prognostic Gene Signature Assay provide the following key features:
- High-throughput workflow allowing each nCounter Dx Analysis System to perform the Prosigna Assay on up to 30 patient samples per eight hour work day and obtain assay results in as little as two days
- Ready-to-use Prosigna Assay consumables, including RNA extraction kits, allowing laboratories to test as little as a single section of formalin-fixed paraffin embedded (FFPE) tumor tissue
- Automated generation of personalized full-color Prosigna Assay patient reports that can be quickly and easily shared electronically with ordering oncologists, and which includes the patient's Prosigna Score and risk category
The nCounter Dx Analysis System is now available for purchase or through reagent rental arrangements in the U.S. and countries that accept the CE Mark. Prosigna testing services are expected to be available from qualified laboratories in the U.S. beginning in the first quarter of 2014.
About the Prosigna™ Breast Cancer Prognostic Gene Signature Assay
Prosigna 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),
hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene
signature initially discovered by
The Prosigna Assay requires minimal hands-on time and runs on
The Prosigna Assay will be available for diagnostic use when ordered by
a physician in the U.S. The Prosigna Assay has been CE-marked and is
available for use by healthcare professionals in the
Prosigna™ Breast Cancer Prognostic Gene Signature Assay Intended Use:
The Prosigna™ Breast Cancer Prognostic Gene Signature Assay is an in
vitro diagnostic assay which uses the gene expression profile of
cells found in breast cancer tissue to assess a patient's risk of
distant recurrence. The assay measures the gene expression profile using
RNA extracted from formalin-fixed, paraffin embedded (FFPE) breast tumor
tissue. This qualitative assay utilizes gene expression data, weighted
together with clinical variables to generate a risk category and
numerical score, for assessment of the risk of distant recurrence of
disease. The assay is performed on the
The Prosigna Breast Cancer Prognostic Gene Signature Assay is indicated in female breast cancer patients who have undergone either mastectomy or breast-conserving therapy in conjunction with locoregional treatment consistent with standard of care, either as:
A prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal 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.
A prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with hormone receptor-positive (HR+), lymph node-positive (one to three positive nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes.
Special Conditions for Use:
Prosigna is not intended for diagnosis, to predict or detect response to therapy, or to help select the optimal therapy for patients.
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 expected market acceptance of the
nCounter Dx Analysis System, the Prosigna Assay, and nCounter Elements
GPRs, and the expected adoption of the Prosigna Assay by clinicians and
their patients. 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 our 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; as well as the other risks set forth in the company's
filings with the
News Provided by Acquire Media