NanoString Technologies Highlights Important Results from Prosigna Decision Impact Study Presented at the 37th Annual CTRC-AACR San Antonio Breast Cancer Symposium

Study Shows that Prosigna Influences Whether Oncologists Recommend Chemotherapy in Real-World Setting

37th Annual CTRC-AACR San Antonio Breast Cancer Symposium

SEATTLE--()--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.

“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.”

“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:

             
a. 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.
 
b. 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.
 

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:

             
c. 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.
 
d. 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.
 

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.

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