NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science
tools for translational research and molecular diagnostic products,
today announced that the results of the first Prosigna® Assay decision
impact study presented at the 37th Annual CTRC-AACR San
Antonio Breast Cancer Symposium (SABCS) showed that the use of the test
significantly changed oncologists’ treatment recommendations. Conducted
in collaboration with Grupo Español de Investigación del Cáncer de Mama
(GEICAM), a Spanish breast cancer research group, this prospective study
of the Prosigna Assay and its impact on the treatment of women with
Estrogen Receptor-Positive (ER+), HER2-negative, node-negative breast
cancer showed that the use of the test informed the oncologists’
recommendation whether or not to treat with adjuvant chemotherapy in
addition to adjuvant endocrine therapy.
“We are very pleased to see that in this study, Prosigna was used by
oncologists to make more informed decisions regarding the administration
of adjuvant chemotherapy for early-stage breast cancer patients,” stated
Brad Gray, President and Chief Executive Officer of NanoString. “Also,
we were pleased to recapitulate the results of our earlier analytical
validation study, which showed that Prosigna can be run at multiple
sites and generate high-quality, consistent results.”
The primary objective of the decision impact study was to characterize
the impact of the Prosigna Assay run on the nCounter Dx System on the
adjuvant therapy recommendations made by medical oncologists (hormonal
therapy, chemotherapy, or chemotherapy and hormonal therapy). In this
unselected, all-comers population of 200 postmenopausal early-stage
breast cancer patients, Prosigna test results led oncologists to change
adjuvant therapy recommendation in 20 percent of patients. Oncologists
modified chemotherapy use based on Prosigna test results with increased
use in patients categorized as high risk and reduced use in patients
categorized as low risk. Specifically, following receipt of the test
results, oncologists recommended chemotherapy for 85 percent of patients
categorized by Prosigna as high risk, compared to only three percent of
patients categorized by Prosigna as low risk.
In addition, tumor samples in the study were tested at two separate
laboratories to evaluate the consistency of results obtained. A high
level of concordance was observed between the results from the two
laboratories, leading the investigators to conclude that the analytical
validity of the Prosigna Assay was confirmed. Additionally, the
investigators concluded that intrinsic subtype determined by
immunohistochemistry was not a reliable substitute for molecular subtype
determined by Prosigna.
Overall, the investigators concluded that Prosigna can be reliably
performed in hospital laboratories to provide useful information beyond
standard clinicopathological variables that oncologists can use to
inform adjuvant treatment recommendations in clinical practice, and that
this study provides additional evidence that Prosigna has analytical
validity and clinical utility in real-world settings.
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.
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, as well as Canada,
Israel, Australia, New Zealand and Hong Kong.
The Prosigna Breast Cancer Prognostic Gene Signature Assay Intended
Use
In the U.S., the Prosigna Assay indication is as follows:
The Prosigna® Breast Cancer Prognostic Gene Signature Assay
is an in vitro diagnostic assay, which is performed on the
NanoString nCounter® Dx Analysis System using FFPE breast tumor tissue
previously diagnosed as invasive breast carcinoma. This qualitative
assay 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 Breast
Cancer Prognostic Gene Signature Assay is indicated in female breast
cancer patients who have undergone surgery in conjunction with
locoregional treatment consistent with standard of care, either as:
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a.
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A prognostic indicator for distant recurrence-free survival at 10
years in postmenopausal women with 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.
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b.
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A prognostic indicator for distant recurrence-free survival at 10
years in postmenopausal women with HR+, lymph node-positive (1–3
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 4 or more positive nodes.
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Special Conditions for Use: Prosigna is not intended for diagnosis, to
predictor detect response to therapy, or to help select the optimal
therapy for patients.
In the European Union, and other countries that recognize the CE
mark, as well as Canada and Australia, the Prosigna Assay indication is
as follows:
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 FFPE breast tumor tissue. The gene
expression data are weighted together with clinical variables to
generate both a subtype (luminal A, luminal B, HER2-enriched, or
basal-like) and a score indicative of the probability of distant
recurrence of disease. The assay is performed on the NanoString
nCounter® Analysis System using FFPE breast tumor tissue previously
diagnosed as invasive breast carcinoma.
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:
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c.
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A prognostic indicator for distant recurrence-free survival at 10
years in postmenopausal women with 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.
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d.
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A prognostic indicator for distant recurrence-free survival at 10
years in postmenopausal women with HR+, lymph node-positive (1-3
positive nodes, or 4 or more positive nodes), Stage II or IIIA
breast cancer to be treated with adjuvant endocrine therapy alone,
when used in conjunction with other clinicopathological factors.
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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 has been employed in life sciences research since it was
first introduced in 2008 and has been cited in over 500 peer-reviewed
publications. The nCounter Analysis 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,
facilitating a wide variety of basic research and translational medicine
applications, including biomarker discovery and validation. The
company’s technology has now been applied to diagnostic use. The
Prosigna Breast Cancer Prognostic Gene Signature Assay together with the
nCounter Dx Analysis System is FDA 510(k) cleared for use as a
prognostic indicator for distant recurrence of breast cancer.
For more information, please visit www.nanostring.com.
The NanoString Technologies logo, NanoString, NanoString
Technologies, nCounter, and Prosigna are registered trademarks or
trademarks of NanoString Technologies, Inc. in various jurisdictions.
Copyright Business Wire 2014