Study Published in The Journal of Clinical Oncology Demonstrates Advantages of NanoString’s ProsignaTM Breast Cancer Assay

  Study Published in The Journal of Clinical Oncology Demonstrates Advantages
  of NanoString’s ProsignaTM Breast Cancer Assay

 Authors Conclude that PAM50-based Assay Provides More Prognostic Information
than Oncotype DX ^® with Better Differentiation of Intermediate and High Risk
                                    Groups

Business Wire

SEATTLE -- July 2, 2013

NanoString Technologies, Inc. (NASDAQ: NSTG), a provider of life science tools
for translational research and molecular diagnostic products, today announced
that the TransATAC clinical validation study for its Prosigna Breast Cancer
Prognostic Gene Signature Assay, which is based on the PAM50 gene signature,
was published in the Journal of Clinical Oncology (JCO)^1. This study,
portions of which were initially presented at the 2011 CTRC-AACR San Antonio
Breast Cancer Symposium, evaluated the ability of three breast cancer tests to
predict risk of distant recurrence after endocrine therapy in postmenopausal
women with hormone receptor-positive (HR+) early-stage breast cancer. The
authors of the study concluded that the PAM50-based assay provides more
prognostic information in endocrine treated patients with HR+ node negative
disease than Oncotype DX^®, with better differentiation of intermediate and
high-risk groups.

The study included 1,017 samples from the landmark ATAC (Arimidex, Tamoxifen,
Alone or in Combination) trial of postmenopausal women with HR+ early-stage
breast cancer treated with five years of endocrine therapy. The study was
performed on RNA extracted from tumor samples by Genomic Health, Inc. for
validation of the Oncotype DX^® Breast Cancer Assay. The goals of the
TransATAC study were to determine if the PAM50 gene signature added prognostic
information to clinical-pathological variables and to compare the performance
of the PAM50 risk of recurrence (ROR) score, the Oncotype DX recurrence score
(RS), and the IHC4 score, derived from immunohistochemical assessment of ER,
PR, HER2 and Ki67 genes, in indicating risk of distant recurrence after
endocrine therapy. All primary and secondary endpoints of the study were met.

Authors of the study reported that the PAM50 ROR score added prognostic
information about the risk of 10-year distant recurrence in addition to that
provided by standard clinical-pathological variables in the analysis of all
patients studied (p < 0.001). Similar results were achieved in all three
prospectively defined clinically important subsets of patients: node-negative
(p < 0.001), node-positive (p = 0.002), and HER2-negative (p < 0.001). In
addition, the study reported that patients with Luminal A subtype had a lower
risk of recurrence than those with the Luminal B subtype further supporting
the biological differences between these groups.

The authors also concluded that the PAM50 ROR score provided more prognostic
information than the widely used Oncotype DX RS. Compared to Oncotype DX RS,
PAM50 ROR score categorized fewer patients as intermediate-risk and more as
high-risk when using prospectively defined risk cutoffs for low, intermediate
and high risk of <10%, 10% to 20% and >20% estimated risk of recurrence,
respectively. Moreover, the authors concluded that the PAM50 ROR score
provided at least as much information as the IHC4 and may provide more
information than IHC4 in the node negative/HER2 negative patient group.

“The publication of the TransATAC study is an important milestone in our
ongoing effort to enable genomic testing for breast cancer in local
laboratories worldwide,” said Brad Gray, President and Chief Executive Officer
of NanoString Technologies. “We look forward to discussing the results and
conclusions of this study with oncologists, pathologists, and payers in the
European Union and other countries that recognize the CE Mark, as we continue
with our commercial launch in those regions.”

The TransATAC clinical validation study, titled “Comparison of PAM50 risk of
recurrence (ROR) score with Oncotype DX and IHC4 for predicting risk of
distant recurrence after endocrine therapy” was published online in JCO, and
can be found at:
http://jco.ascopubs.org/content/early/2013/06/25/JCO.2012.46.1558.abstract.

About the Prosigna^™ Breast Cancer Prognostic Gene Signature Assay

Prosigna assesses risk of recurrence (ROR) in postmenopausal women with
early-stage hormone receptor positive (HR+) breast cancer. The Prosigna Assay
has received a CE mark 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; it is pending 510(k) clearance with the Food and Drug
Administration and is not available for sale in the United States.

Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D.
and colleagues, the Prosigna Assay provides a subtype classification based on
the fundamental biology of an individual’s breast tumor (referred to as
intrinsic subtyping), and a prognostic score (referred to as the ROR score).
The ROR score estimates the probability of cancer recurrence within 10 years
in postmenopausal women with HR+ early-stage breast cancer who have been
treated with endocrine therapy alone. The Prosigna Assay was validated in two
clinical studies with more than 2,400 patient samples and results were
presented at the 2011 and 2012 San Antonio Breast Cancer Symposiums.

The Prosigna Assay requires minimal hands-on time and can be offered to
healthcare professionals in qualified pathology laboratories, in the European
Union and other countries that recognize the CE Mark and in which Prosigna is
registered, empowering oncologists and pathologists to manage the diagnostic
evaluation of breast cancer patients locally and using the laboratory
infrastructure already in place. The Prosigna Assay runs on NanoString’s
proprietary nCounter Analysis system, which offers a reproducible and
cost-effective way to profile many genes simultaneously with high sensitivity
and precision. In North America, the nCounter Analysis System is not intended
for diagnostic use, but is available for “Research Use Only”.

For more information, please visit www.prosigna.com.

About NanoString Technologies, Inc.

NanoString Technologies is a provider of 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 220 peer-reviewed
publications, has also now been applied to diagnostic use in the European
Union. The system 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 kit to
be marketed through the company’s recently formed diagnostics business.

The nCounter Analysis System is available for “Research Use Only” in North
America. For more information, please visit www.nanostring.com.

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.

^1 Dowsett, M., Sestak, I., Lopez-Knowles, E. et al (2013) Comparison of PAM50
risk of recurrence (ROR) score with Oncotype Dx and IHC4 for predicting risk
of distant recurrence after endocrine therapy Journal of Clinical Oncology
online,
http://jco.ascopubs.org/content/early/2013/06/25/JCO.2012.46.1558.abstract.

Contact:

Investor Contact:
For NanoString Technologies
Lynn Pieper of Westwicke Partners,415-202-5678
lynn.pieper@westwicke.com
or
Media Contact:
For NanoString Technologies
Colin Sanford, 203-340-2441
colin@bioscribe.com
 
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