|[March 13, 2014]
Newly Published Analytical Validation Study Shows Precision and Reproducibility of PAM50-Based Prosigna Breast Cancer Assay in Multiple Clinical Testing Laboratories
SEATTLE --(Business Wire)--
NanoString Technologies, Inc., (NASDAQ:NSTG) a provider of life science
tools for translational research and molecular diagnostic products,
today announced that a study published online in the journal BMC
Cancer demonstrates the analytical validity of the PAM50-based
Prosigna™ Breast Cancer Prognostic Gene Signature Assay.
Based on highly concordant results across multiple clinical laboratory
sites, technicians, and manufacturing lots of Prosigna reagents, the
authors concluded that the study provides a strong body of evidence
supporting the decentralized use of the Prosigna Assay on the nCounter
Dx Analysis System as a prognostic tool for the risk of recurrence (ROR)
in selected breast cancer patients.
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 British Columbia Cancer Agency and
Washington University and can be found online at: http://www.biomedcentral.com/1471-2407/14/177/abstract.
"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 Torsten Nielsen, Professor of Pathology
based at the British Columbia Cancer Agency and lead author on the
publication. "Results from this new study demonstrate that the Prosigna
assay has been shown to have both analytic and clinical validity, as
required by the EGAPP (Evaluation of Genomic Applications in Practice
and Prevention) working-group Standards."
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 Brad Gray, President and Chief
Executive Officer of NanoString Technologies. "This publication will be
an important element in our submissions to payers, confirming analytic
reproducibility and, together with our body of clinical data and FDA
clearance, demonstrating the strong rationale for 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 Charles Perou, Ph.D. and
colleagues, the Prosigna Assay is an in vitro diagnostic tool
that utilizes gene expression data weighted together with clinical
variables to generate a risk category and numerical score to assess a
patient's risk of distant recurrence of disease. The Prosigna Assay
measures gene expression levels of RNA extracted from formalin-fixed
paraffin embedded (FFPE) breast tumor tissue previously diagnosed as
invasive breast carcinoma.
The Prosigna Assay requires minimal hands-on time and runs on
NanoString's proprietary nCounter® Dx Analysis System, which
offers a reproducible and cost-effective way to profile many genes
simultaneously with high sensitivity and precision.
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.
In the United States, the Prosigna Assay is available for diagnostic use
when ordered by a physician. The Prosigna Assay has been CE-marked and
is available for use by healthcare professionals in the European Union
and other countries that recognize the CE Mark and in which Prosigna is
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.
About NanoString Technologies, Inc.
NanoString Technologies provides life science tools for translational
research and molecular diagnostic products. The company's nCounter®
Analysis System, which has been employed in basic and translational
research since it was first introduced in 2008 and cited in more than
360 peer-reviewed publications, has also now been applied to diagnostic
use as the nCounter Dx Analysis System. The company's technology offers
a cost-effective way to easily profile the expression of hundreds of
genes, miRNAs, or copy number variations, simultaneously with high
sensitivity and precision. The company's technology enables a wide
variety of basic research and translational medicine applications,
including biomarker discovery and validation. The nCounter-based Prosigna™
Breast Cancer Prognostic Gene Signature Assay is the first in vitro
diagnostic assay to be marketed through the company's diagnostics
business. The nCounter Dx Analysis System is FDA 510(k) cleared for use
with the Prosigna Breast Cancer Prognostic Gene Signature Assay. To
date, it has not been cleared by the FDA for other indications or for
use with other assays.
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; as well as the
other risks set forth in the company's filings with the Securities and
Exchange Commission. These forward-looking statements speak only as of
the date hereof. NanoString Technologies disclaims any obligation to
update these forward-looking statements.
The NanoString Technologies logo, NanoString, NanoString
Technologies, and nCounter are registered trademarks, and Prosigna is a
trademark of NanoString Technologies, Inc.
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