Download Prosigna Annotated Patient Report

Prognostic information to
enhance treatment decisions
Prosigna Annotated Patient Report
TM
Facilitating an integrated approach to the
diagnosis and treatment of breast cancer
This guide provides an explanation of the Prosigna Patient Report generated
by the nCounter® Dx Analysis System, which may help interpret and
present results.
Intended use: 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.1
Special conditions for use: Prosigna is not intended for diagnosis, to predict
or detect response to therapy, or to help select the optimal therapy for patients.1
Understanding the Prosigna™ Patient Report
• Prosigna Score: Derived from a proprietary algorithm based on the PAM50 gene signature, the Prosigna Score
is a numerical value on a 0 to 100 scale that correlates with the probability of distant recurrence within 10 years1
• Risk group: Based on the Prosigna Score and nodal status, risk group is provided to allow interpretation of the
Prosigna Score by using cutoffs related to clinical outcome in tested patient populations1
The patient’s tumor size
and nodal status are
required to determine
her Prosigna Score and
risk group.1
Patient
Specimen
ID #:
Tumor Size: ≤ 2cm
Comments
Date Reported:
Lymph Nodes: node-negative
Assay Description:
The Prosigna™ breast cancer gene signature assay measures the expression of 58 different genes to report the Prosigna Score, which is used along with
the patient’s nodal status to assign a risk classification defined by prespecified Prosigna Score cutpoints.The Prosigna Score is derived from a proprietary
algorithm based on the PAM50 gene signature1, and includes information on the correlation of the tumor’s gene expression with four prototypical PAM50
molecular profiles, as well as proliferation and the pathologic tumor size.
Patient Prosigna Score*:
16
0
Low risk
Intermediate risk
High risk
100
Low Risk
* The Prosigna Score ranges from 0 through 100 and correlates with the probability of distant recurrence (DR) in the tested population. Risk
classification is provided to guide the interpretation of the Prosigna Score using cutoffs related to clinical outcome.
Clinical Trial Results:
Probability of Distant Recurrence:
In the clinical validation study, patients who were node-negative, with a Prosigna Score of 16 were in the low risk group.
The low risk population averaged a 3% probability of distant recurrence at 10 years.
Probability of Distant Recurrence at 10 Years (%)
The Prosigna algorithm was used in retrospective analysis of the ABCSG-8 clinical trial which included more than 1400 patients with varying risks of distant
recurrence. The retrospectively fitted model relating Prosigna Score to 10-year distant recurrence for node-negative patients in the ABCSG-8 study is
displayed below.†
100
Group
Average
[95% CI]
80
Low risk
Intermediate risk
3% [2%-6%]
• Node-negative patients: 10-year distant recurrence-free survival (DRFS) rates were >95% for the low-risk group,
90.4% for the intermediate-risk group, and <85% for the high-risk group1
• Node-positive patients: 10-year DRFS rates were 94.2% for the low-risk group and 75.8% for the high-risk group1
The data and table
in the Clinical Trial
Results section reflect
results seen in your
patient’s nodal status
and risk group from
the broader ABCSG-8
validation study
population.
16% [11%-22%]
Specimen
ID #:
Tumor Size: ≤ 2cm
Comments
Date Reported:
Lymph Nodes: node-negative
Clinical Trial Results:
Clinical Validation Study
Prognosis for node-negative breast cancer patients was determined based on the probability of distant recurrence (DR) for this patient population in the
validation study ABCSG-8. This study analyzed 1,047 node-negative samples using a prospectively defined analysis plan. The data shown are for postmenopausal women with hormone receptor-positive, node-negative, Stage I and II breast cancer that received 5 years of endocrine therapy.*
Probability of DR for node-negative Patients
Prespecified Patient Risk Group
ABCSG-82
Low Risk [95% CI]
Intermediate Risk [95% CI]
High Risk [95% CI]
3% [2%-6%]
10% [7%-14%]
16% [11%-22%]
100
The Prosigna Score classifies node-negative patients
as low, intermediate, or high-risk based on prespecified
thresholds that indicate probability of DR at 10 years.
In the ABCSG-8 clinical validation study, the probability
of DR at 10 years for low-risk, node-negative patients
was 3% (95% CI: 2%–6%), while the probability of DR
at 10 years for high-risk patients was 16% (95% CI:
11%–22%).
90
80
70
0
Low Risk
Intermediate Risk
High Risk
0
2
4
6
8
10
Follow-up Time (Years)
60
The Kaplan-Meier plot
shows the probability of
distant recurrence (DR)
for each risk group,
based on DRFS within
the similar nodal status
patient population
from the clinical
validation study.1
* See Package Insert for further information on therapy regimens and tested patient population. It is unknown whether these findings can be extended to
other patient populations or treatment schedules.
40
REFERENCES: 1. Parker JS, et al., Supervised Risk Predictor of Breast Cancer Based on Intrinsic Subtypes. Journal of Clinical Oncology, v27 No. 8 (2009) 1160-1167
2. Prosigna Package Insert
3. Gnant M, et al., P2-10-02, Clinical Validation of the PAM50 risk of recurrence (ROR) score for predicting residual risk of distant
recurrence (DR) after endocrine therapy in postmenopausal women with HR+ early breast cancer (EBC): An ABCSG study, SABCS 2012.
20
0
0
20
40
60
80
100
Modeled probability
95% Confidence Interval (CI)
Observed probability‡
Data apply to patients being treated with endocrine therapy for 5 years as in the tested patient population. See Package Insert for further information
on therapeutic regimens and tested patient population. It is unknown whether these findings can be extended to other patient populations or
treatment schedules. ‡Average DR rate observed in ABCSG-8 for patients within 10 Prosigna Score units.
NanoString Technologies, Inc. 530 Fairview Avenue N | Suite 2000 | Seattle, Washington 98109 | 1-206-378-6266 | nanostring.com
NanoString Technologies, Inc. 530 Fairview Avenue N | Suite 2000 | Seattle, Washington 98109 | 1-206-378-6266 | nanostring.com
© 2013 NanoString Technologies, Inc.
Prosigna assay results are based on a large validation
data set of postmenopausal women with early-stage
breast cancer, including both node-negative and
node-positive patients (see table at right).1 The Prosigna
Patient Report is customized and includes only those
results relevant to your patient’s nodal status.
22
Patient
DRFS by Risk Group for node-negative Patients3
High risk
10% [7%-14%]
Prosigna score
†
The Prosigna Score
is derived from a
proprietary algorithm
and is reported on a
scale from 0 to 100.
Risk group and the
Prosigna Score are
dependent on the
patient’s nodal status.1
Page 2 of the Prosigna Patient Report provides context for your patient’s reported risk group based on the
results of a large clinical validation study, ABCSG-8.1 Both the Prosigna Score and risk group add statistically significant
prognostic information beyond other clinical variables for node-negative and node-positive patients (P<0.0001).1,2
Percentage without distant recurrence
Page 1 of the Prosigna Patient Report provides two customized outputs to determine your patient’s
probability of distant recurrence over 10 years:
For more information, visit PROSIGNA.com or e-mail [email protected]
For more information, visit PROSIGNA.com or e-mail [email protected]
© 2013 NanoString Technologies, Inc.
Number of patients
Nodal status
1047
Node-negative
382
Node-positive
Number of patients by
risk group and nodal
status in the clinical
validation study1
Risk group
Node-negative
Node-positive
Low
487 (47%)
158 (41%)
Intermediate
335 (32%)
N/A
High
225 (21%)
224 (59%)
3
Probability of Distant Recurrence:
In the clinical validation study, patients who were node-negative, with a Prosigna Score of 16 were in the low risk group.
The low risk population
averaged a 3% probability of distant recurrence at 10 years.
™
Node-negative Prosigna Patient Report
ID #:
Date Reported:
100
Assay Description:
Group
Average
[95% CI]
Low risk
Specimen
80
Intermediate risk
Comments
Tumor Size: ≤ 2cm
3% [2%-6%]
Lymph Nodes: node-negative
10% [7%-14%]
Patient Prosigna Score*:
The Prosigna Score is
related to an individual
patient’s 10-year risk
of DR.1
A
•Low risk: <10% predicted risk1
BClinical Trial Results:
•High risk: >20%
predicted risk1
Intermediate risk
High risk
100
Low Risk
* The Prosigna Score ranges from 0 through 100 and correlates with the probability of distant recurrence (DR) in the tested population. Risk
classification is provided to guide the interpretation of the Prosigna Score using cutoffs related to clinical outcome.
40
Probability of Distant Recurrence:
The Prosigna algorithm was used in retrospective analysis of the ABCSG-8 clinical trial which included more than 1400 patients with varying risks of distant
recurrence. The retrospectively fitted model relating Prosigna Score to 10-year distant recurrence for node-negative patients in the ABCSG-8 study is
displayed below.†
100
Group
Average
[95% CI]
80
60
40
20
Low risk
Intermediate risk
3% [2%-6%]
High risk
10% [7%-14%]
0
16% [11%-22%]
0
20
20
0
0
20
40
60
Prosigna score
80
100
To determine the
relationship between
the Prosigna Score and
estimated 10-year risk
of DR, plot your
patient’s score along
40
the x-axis, then draw
a horizontal line to
the y-axis.
Comments
16% [11%-22%]
Tumor Size: ≤ 2cm
Date Reported:
In the clinical validation study, patients who were node-negative, with a Prosigna Score of 16 were in the low risk group.
The low risk population averaged a 3% probability of distant recurrence at 10 years.
Probability of Distant Recurrence at 10 Years (%)
•Intermediate risk: 10%
to 20% predicted risk1
16
0
60
Low risk
Specimen
ID #:
Page 2 of the
Prosigna Patient Report
contains prognostic
information from the
node-negative patients
in the ABCSG-8
clinical validation
study (n=1047).
The Prosigna™ breast cancer gene signature assay measures the expression of 58 different genes to report the Prosigna Score, which is used along with
the patient’s nodal status to assign a risk classification defined by prespecified Prosigna Score cutpoints.The Prosigna Score is derived from a proprietary
algorithm based on the PAM50 gene signature1, and includes information on the correlation of the tumor’s gene expression with four prototypical PAM50
molecular profiles, as well as proliferation and the pathologic tumor size.
High risk
Patient
Lymph Nodes: node-negative
CClinical Trial Results:
Clinical Validation Study
Prognosis for node-negative breast cancer patients was determined based on the probability of distant recurrence (DR) for this patient population in the
validation study ABCSG-8. This study analyzed 1,047 node-negative samples using a prospectively defined analysis plan. The data shown are for postmenopausal women with hormone receptor-positive, node-negative, Stage I and II breast cancer that received 5 years of endocrine therapy.*
Probability of DR for node-negative Patients
ABCSG-8
Prespecified Patient Risk Group
2
Low Risk [95% CI]
Intermediate Risk [95% CI]
High Risk [95% CI]
3% [2%-6%]
10% [7%-14%]
16% [11%-22%]
DRFS by Risk Group for node-negative Patients3
Percentage without distant recurrence
Patient
Probability of Distant Recurrence at 10 Years (%)
The Prosigna algorithm was used in retrospective analysis of the ABCSG-8 clinical trial which included more than 1400 patients with varying risks of distant
recurrence. The retrospectively fitted model relating Prosigna Score to 10-year distant recurrence for node-negative patients in the ABCSG-8 study is
displayed below.†
100
The Prosigna Score classifies node-negative patients
as low, intermediate, or high-risk based on prespecified
thresholds that indicate probability of DR at 10 years.
In the ABCSG-8 clinical validation study, the probability
of DR at 10 years for low-risk, node-negative patients
was 3% (95% CI: 2%–6%), while the probability of DR
at 10 years for high-risk patients was 16% (95% CI:
11%–22%).
90
80
70
0
Low Risk
Intermediate Risk
High Risk
0
2
4
6
8
10
Follow-up Time (Years)
60
Prosigna score
* See Package Insert for further information on therapy regimens and tested patient population. It is unknown whether these findings can be extended to
other patient populations or treatment schedules.
80
100
REFERENCES: 1. Parker JS, et al., Supervised Risk Predictor of Breast Cancer Based on Intrinsic Subtypes. Journal of Clinical Oncology, v27 No. 8 (2009) 1160-1167
2. Prosigna Package Insert
The Kaplan-Meier plot
shows the 10-year
DRFS rate for each risk
group within the
node-negative patient
population from the
ABCSG-8 clinical
validation study.
Both the intermediateand high-risk groups
are significantly
different from the
low-risk group.1
Modeled probability
95% Confidence Interval (CI)
Observed probability‡
3. Gnant M, et al., P2-10-02, Clinical Validation of the PAM50 risk of recurrence (ROR) score for predicting residual risk of distant
recurrence (DR) after endocrine therapy in postmenopausal women with HR+ early breast cancer (EBC): An ABCSG study, SABCS 2012.
Modeled probability
95% Confidence Interval (CI)
Observed probability‡
Data apply to patients being treated with endocrine therapy for 5 years as in the tested patient population. See Package Insert for further information
on therapeutic regimens and tested patient population. It is unknown whether these findings can be extended to other patient populations or
treatment schedules. ‡Average DR rate observed in ABCSG-8 for patients within 10 Prosigna Score units.
NanoString Technologies, Inc.
NanoString Technologies, Inc.
†
†
Data apply to patients being treated with endocrine therapy for 5 years as in the tested patient population. See Package Insert for further information
on therapeutic regimens and tested patient population. It is unknown whether these findings can be extended to other patient populations or
treatment schedules. ‡Average DR rate observed in ABCSG-8 for patients within 10 Prosigna Score units.
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© 2013 NanoString Technologies, Inc.
A
NanoString Technologies, Inc.
Patient Prosigna Score
Based on a clinical validation study involving over 1400 patients, the Prosigna Score and risk group add
statistically significant prognostic information beyond other clinical variables (P<0.0001).1,2 This information
can be used in combination with other patient risk factors to determine whether adjuvant chemotherapy
may be required.3,4
Probability of Distant Recurrence
Estimation of risk is derived from the rate of 10-year DR within the node-negative clinical trial population.
There is a continuous relationship between Prosigna Score and predicted 10-year risk of DR, which can be
used to extrapolate your patient’s predicted 10-year risk of DR.1,4
44
© 2013 NanoString Technologies, Inc.
For more information, visit PROSIGNA.com or e-mail [email protected]
C Clinical
530 Fairview Avenue N | Suite 2000 | Seattle,
Washington
98109Results
| 1-206-378-6266 | nanostring.com
Trial
The Prosigna Score section contains two key pieces of information specific to your patient1:
1. Prosigna Score provided as a©numerical
value on aTechnologies,
0 to 100 scale Inc.
2013 NanoString
2.Risk group (low, intermediate, or high) based on cutoffs related to clinical outcome
B
530 Fairview Avenue N | Suite 2000 | Seattle, Washington 98109 | 1-206-378-6266 | nanostring.com
For more information, visit PROSIGNA.com or e-mail [email protected]
For more
Prosigna has been validated in a large clinical validation study (N=1478) that includes both node-negative andvisit
node-positive
patients.1,2 Results
from the [email protected]
node-negative patient population are presented on page 2 information,
PROSIGNA.com
or e-mail
of the Prosigna Patient Report, so you can interpret your patient’s Prosigna Score in the context of the results seen in similar patients from the clinical validation study.
Summary of ABCSG-8 study
•
Samples: 1478 FFPE breast tumor samples from postmenopausal women with hormone receptor–
positive breast cancer who were randomized prior to treatment to 2 years of adjuvant tamoxifen,
followed by either 3 years of anastrozole or 3 years of adjuvant tamoxifen1,2
• Objective: Determine if the Prosigna Score and risk group add prognostic information beyond
other clinical variables1,2
•
Conclusions: The Prosigna Score and risk group add statistically significant prognostic information
beyond other clinical variables (P<0.0001). Risk groups stratify patients according to DRFS, with
10-year DRFS rates of >95% for the low-risk group, 90.4% for the intermediate-risk group, and <85%
for the high-risk group1,2
5
Node-positive Prosigna™ Patient Report
Patient
Specimen
Patient
Specimen
ID #:
Tumor Size: ≤ 2cm
ID #:
Tumor Size: ≤ 2cm
Date Reported:
Lymph Nodes: node-positive (1-3 nodes)
Date Reported:
Lymph Nodes: node-positive (1-3 nodes)
Assay Description:
The Prosigna™ breast cancer gene signature assay measures the expression of 58 different genes to report the Prosigna Score, which is used along with
the patient’s nodal status to assign a risk classification defined by prespecified Prosigna Score cutpoints.The Prosigna Score is derived from a proprietary
algorithm based on the PAM50 gene signature1, and includes information on the correlation of the tumor’s gene expression with four prototypical PAM50
molecular profiles, as well as proliferation and the pathologic tumor size.
Patient Prosigna Score*:
D
16
0
Low risk
High risk
100
Low Risk
* The Prosigna Score ranges from 0 through 100 and correlates with the probability of distant recurrence (DR) in the tested population. Risk
classification is provided to guide the interpretation of the Prosigna Score using cutoffs related to clinical outcome. Prosigna Scores greater than
80 are considered high risk, and the score is not reported.
Clinical Trial Results:
Probability of Distant Recurrence:
In the clinical validation study, patients who were node-positive (1-3 nodes), with a Prosigna Score of 16 were in the low risk group.
The low risk population averaged a 6% probability of distant recurrence at 10 years.
The Prosigna algorithm was used in retrospective analysis of the ABCSG-8 clinical trial which included more than 1400 patients with varying risks of distant
recurrence. The retrospectively fitted model relating Prosigna Score to 10-year distant recurrence for node-positive (1-3 nodes) patients in the ABCSG-8
study is displayed below.†
Probability of Distant Recurrence at 10 Years (%)
All node-positive
patients are classified
into one of 2 risk
groups based on their
Prosigna Score. The
cutoff between low risk
and high risk is 40.1
100
Group
Average
[95% CI]
80
Low risk
High risk
6% [3%-12%]
24% [19%-31%]
60
40
20
0
0
20
40
Prosigna score
60
80
To determine the
relationship between
the Prosigna Score and
estimated 10-year risk
of DR, plot your patient’s
score along the x-axis,
then draw a horizontal
line to the y-axis. Due to
the small sample size of
node-positive patients
with scores >80, the
exact relationship of
the Prosigna Score to
probability of DR could
not be established
beyond 80.1
Page 2 of the
Prosigna Patient Report
contains prognostic
information from the
node-positive patients
in the ABCSG-8
clinical validation
study (n=382).
Comments
EClinical Trial Results:
Clinical Validation Study
Prognosis for node-positive (1–3 nodes) breast cancer patients was determined based on the probability of distant recurrence (DR) for this patient
population in the validation study ABCSG8. This study analyzed 382 node-positive (1–3 nodes) samples using a prospectively defined analysis plan. The
data shown are for post-menopausal women with hormone receptor-positive, node-positive (1–3 nodes), Stage II breast cancer that received 5 years of
endocrine therapy.*
Probability of DR for node-positive (1–3 nodes) Patients
ABCSG-8
Prespecified Patient Risk Group
2
Low Risk [95% CI]
High Risk [95% CI]
6% [3%–12%]
24% [19%–31%]
DRFS by Risk Group for node-positive (1–3 nodes) Patients3
Percentage without distant recurrence
Comments
100
The Prosigna Score classifies node-positive (1–3 nodes)
patients as low or high risk based on prespecified thresholds
that indicate probability of DR at 10 years. In the ABCSG-8
clinical validation study, the probability of DR at 10 years
for low-risk, node-positive (1–3 nodes) patients was 6%
(95% CI: 3%–12%), while the probability of DR at 10 years
for high-risk patients was 24% (95% CI: 19%–31%).
90
80
70
Low Risk
0
High RIsk
0
2
4
6
8
10
Follow-up Time (Years)
* See Package Insert for further information on therapy regimens and tested patient population. It is unknown whether these findings can be extended to
other patient populations or treatment schedules.
REFERENCES: 1. Parker JS, et al., Supervised Risk Predictor of Breast Cancer Based on Intrinsic Subtypes. Journal of Clinical Oncology, v27 No. 8 (2009) 1160-1167
The Kaplan-Meier plot
shows the 10-year
DRFS rate for each
risk group within the
node-positive patient
population from the
ABCSG-8 clinical
validation study.
The high-risk group
is significantly
different from the
low-risk group.1
2. Prosigna Package Insert
3. Gnant M, et al., P2-10-02, Clinical Validation of the PAM50 risk of recurrence (ROR) score for predicting residual risk of distant
recurrence (DR) after endocrine therapy in postmenopausal women with HR+ early breast cancer (EBC): An ABCSG study, SABCS 2012.
100
Modeled probability
95% Confidence Interval (CI)
Observed probability‡
Due to small sample size of patients with scores greater than 80 in the clinical validation study, the exact relationship of the Prosigna Score to probability
of DR could not be established with a retrospective model fitting.
†
Data apply to patients being treated with endocrine therapy for 5 years as in the tested patient population. See Package Insert for further information
on therapeutic regimens and tested patient population. It is unknown whether these findings can be extended to other patient populations or treatment
schedules. ‡Average DR rate observed in ABCSG-8 for patients within 10 Prosigna Score units.
NanoString Technologies, Inc.
D
NanoString Technologies, Inc. 530 Fairview Avenue N | Suite 2000 | Seattle, Washington 98109 | 1-206-378-6266 | nanostring.com
530 Fairview Avenue N | Suite 2000 | Seattle, Washington 98109 | 1-206-378-6266 | nanostring.com
For more information, visit PROSIGNA.com or e-mail [email protected]
© 2013 NanoString Technologies, Inc.
© 2013 NanoString Technologies, Inc.
Patient Prosigna Score1
E
The analysis for node-positive patients was limited to two risk categories since the ABCSG-8 study included a
smaller number of node-positive patients (n=382) relative to the number of node-negative patients (n=1047).
The scale and cutoffs between risk groups differ for node-negative and node-positive patients, as shown below.
Node-negative
Low risk
Intermediate risk
High risk
0
Node-positive
0
66
100
Low risk
High risk
100
For more information, visit PROSIGNA.com or e-mail [email protected]
Clinical Trial Results
Prosigna has been validated in a large clinical validation study (N=1478) that includes both node-negative and node-positive patients.1,2 Results from the node-positive patient population are presented on page 2 of the Prosigna Patient Report, so you can interpret your patient’s Prosigna Score in the context of the results seen in similar patients from the clinical validation study.
Summary of ABCSG-8 study
•
Samples: 1478 FFPE breast tumor samples from postmenopausal women with hormone receptor–
positive breast cancer who were randomized prior to treatment to 2 years of adjuvant tamoxifen,
followed by either 3 years of anastrozole or 3 years of adjuvant tamoxifen1,2
• Objective: Determine if the Prosigna Score and risk group add prognostic information beyond
other clinical variables1,2
•
Conclusions: The Prosigna Score and risk group add statistically significant prognostic information
beyond other clinical variables (P<0.0001). Risk groups stratify patients according to DRFS, with 10-year
DRFS rates of 94.2% for the low-risk group and 75.8% for the high-risk group1,2
7
Contact us to learn how Prosigna™
can enhance your clinical practice
For more information, visit Prosigna.com
or e-mail [email protected]
References: 1. Prosigna [Package Insert]. Seattle, WA: NanoString Technologies, Inc; 2013. 2. Gnant M, Filipits M,
Mlineritsch B, et al. Clinical validation of the PAM50 risk of recurrence (ROR) score for predicting residual risk of
distant-recurrence (DR) after endocrine therapy in postmenopausal women with HR+ early breast cancer (EBC):
an ABCSG study. Presented at: San Antonio Breast Cancer Symposium; December 4-8, 2012; San Antonio, TX.
Abstract P2-10-02. 3. Data on file. NanoString Technologies, Inc. 4. Dowsett M, Sestak I, Lopez-Knowles E, et al.
Comparison of PAM50 risk of recurrence score with Oncotype DX and IHC4 for predicting risk of distant
recurrence after endocrine therapy. J Clin Oncol. 2013;31(22):2783-2790.
US contact information:
NanoString Technologies, Inc.
530 Fairview Ave N, Suite 2000
Seattle, WA 98109
Phone: 888-358-NANO
(888-358-6266)
Fax: 206-378-6288
Web site: nanostring.com
© 2013 NanoString Technologies, Inc. All rights reserved. NanoString, the NanoString
Technologies logo, nCounter, Prosigna and the Prosigna logo are trademarks and/or
registered trademarks of NanoString Technologies, Inc. in various jurisdictions.