Successful Validation on the nCounter Dx Analysis System Supports
‘Decentralized' Use of the Prosigna Assay in
The study, titled, "Analytic Validation of the PAM50 based Prosigna
Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis
System Using Formalin Fixed Paraffin-Embedded Breast Tumor Specimens"
was conducted by researchers from the
"To date, multi-gene breast cancer clinical assays have largely been
limited to centralized reference laboratories due to the complexity of
performing these tests," said
The aim of this study was to assess the analytic robustness of the Prosigna Assay run on the nCounter Dx Analysis System at qualified laboratories. Analytic precision was evaluated from 540 replicate assays of five tumor RNA samples (108 replicates per sample), resulting in less than a one-point standard deviation in ROR score on a 0-100 point scale, and 100 percent site-to-site concordance in reporting subtype and risk group results. Analytic reproducibility was established by assaying 43 tissue samples at multiple laboratories including all sources of variation from tissue review by a local pathologist through to assay results. The results were highly reproducible and, importantly, there was a negligible contribution of multiple operators and sites to the overall variance in the ROR score.
"The results from this analytical validation study demonstrate that the
Prosigna Assay on the nCounter Dx Analysis System is user friendly and
that local laboratory pathologists can generate precise and reproducible
results with the Prosigna Assay," said
About the Prosigna™ Breast Cancer Prognostic Gene Signature Assay and 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), 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 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 Breast Cancer 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:
In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:
(1) 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 or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 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 4 or more positive nodes.
Special Conditions for Use:
The Prosigna Assay 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 ability of the published data to
support decentralized use of the nCounter Dx Analysis System and the
Prosigna Assay and reimbursement for the related testing services.
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
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