Study Confirms Ability of the Prosigna Assay to Assess Risk of Late Distant Recurrence in Postmenopausal Women With Estrogen

  Study Confirms Ability of the Prosigna Assay to Assess Risk of Late Distant
  Recurrence in Postmenopausal Women With Estrogen Receptor-Positive Breast
  Cancer

Authors Conclude that the PAM50-based Prosigna Assay can Predict Risk of Late
         Distant Recurrence Between Years Five and 15 after Diagnosis

Business Wire

SEATTLE -- February 12, 2014

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 Clinical Cancer Research showed that the
PAM50 assay, on which the company’s Prosigna^™ Breast Cancer Prognostic Gene
Signature Assay is based, accurately assessed the risk of late distant
recurrence in postmenopausal women with estrogen receptor-positive (ER+)
early-stage breast cancer. The study, titled, “The PAM50 Risk-of-Recurrence
Score Predicts Risk for Late Distant Recurrence after Endocrine Therapy in
Postmenopausal Women with Endocrine-Responsive Early Breast Cancer” was
conducted by researchers from the Austrian Breast & Colorectal Cancer Study
Group and can be found online at:
http://clincancerres.aacrjournals.org/content/early/2014/02/11/1078-0432.CCR-13-1845.abstract.

“There is an urgent unmet clinical need to accurately differentiate breast
cancer patients who remain at high risk of distant recurrence beyond five
years after diagnosis,” said senior author Michael Gnant, M.D., Professor at
the Medical University of Vienna in Austria. “Prosigna’s ability to predict
late recurrences may enable identification of patients with
endocrine-responsive breast cancer who can be spared extended adjuvant therapy
in the future.”

Study authors found that the Prosigna Breast Cancer Assay significantly
increased prognostic accuracy with respect to late distant recurrence compared
to a score based on clinical factors alone. Between years five and 15 after
diagnosis in patients who had not had a recurrence at five years, patients
categorized as low risk by the Prosigna Assay demonstrated a risk of distant
recurrence of 2.4 percent compared to a risk of 17.5 percent in the high-risk
group. The ability to accurately assess risk of late distant recurrence was
observed for patients with both node-positive and node-negative disease.

“The ability to stratify patients according to risk of late distant recurrence
significantly differentiates the Prosigna Assay from other genomic-based
breast cancer assays,” said Brad Gray, President and Chief Executive Officer
of NanoString Technologies. “We believe that this feature provides the
potential to expand the clinical utility of the Prosigna Assay, helping to
inform treatment decisions that physicians struggle with today.”

Results described in the Clinical Cancer Research paper build on data
presented at the 2013 San Antonio Breast Cancer Symposium as well as a paper
recently published in the Journal of the National Cancer Institute (JNCI).
Authors of the JNCI paper found that the PAM50 gene signature was better than
Oncotype DX^® and IHC4 Assays at categorizing patients into low and high risk
for late distant recurrence of disease (see
www.nanostring.com/company/corp_press_release?id=94).

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 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. The nCounter Elements^™ General Purpose Reagents (GPRs)
offered by NanoString provide further flexibility by enabling laboratories to
develop their own gene expression, copy number variation, and gene fusion
signatures.

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 registered.

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:

       A prognostic indicator for distant recurrence-free survival at 10 years
       in postmenopausal women with Hormone Receptor-Positive (HR+), lymph
1.   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
2.     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:

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.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, including statements
regarding the potential for Prosigna to identify patients who can be spared
extended endocrine therapy, to expand the clinical utility of Prosigna and to
differentiate Prosigna from first-generation genomic breast cancer assays.
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. Oncotype DX is a registered trademark of Genomic Health,
Inc.

Contact:

Investor Contact:
Westwicke Partners for NanoString Technologies
Lynn Pieper, 415-202-5678
lynn.pieper@westwicke.com
or
Media Contact:
Bioscribe Inc. for NanoString Technologies
Maurissa Messier, 760-539-7417
Maurissa@bioscribe.com
 
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