PAM50-Based Prosigna Breast Cancer Assay Helps to Identify Patients at Risk of Late Distant Recurrence in a Combined Analysis of 2,137 Patients Prosigna Combined Analysis of TransATAC and ABCGS-8 Data Presented at the 2013 San Antonio Breast Cancer Symposium SEATTLE and SAN ANTONIO -- December 13, 2013 -- NanoString Technologies, Inc. (NASDAQ: NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced new results from a combined analysis of the Austrian Breast & Colorectal Cancer Study Group 8 (ABCSG-8) and Trans-Arimidex, Tamoxifen, Alone or in Combination (TransATAC) studies. These results, which evaluated samples from 2,137 patients, suggest that the PAM50-based Prosigna™ Breast Cancer Prognostic Gene Signature Assay may help identify women with late distant recurrence after five years of endocrine treatment. Using the Prosigna Assay, the study investigators classified patient tumors by subtype and found that patients with Luminal B subtype have three times higher risk of late distant recurrence than patients with Luminal A subtype tumors1. Results were presented today at the 2013 San Antonio Breast Cancer Symposium. “Women with estrogen receptor positive breast cancer have a high risk of recurrence for at least 10 years after diagnosis, even after five years of endocrine therapy. To provide better care for these women, more informative biomarkers are needed to help predict risk of late recurrence,” said Ivana Sestak, PhD, The Centre for Cancer Prevention, Wolfson Institute of Prevention Medicine, Queen Mary University and lead investigator of this study. “As a result of our study, we determined that the risk of recurrence score, or ROR score generated by the PAM50- powered Prosigna Assay provides significant prognostic information that may be used by oncologists and pathologists to help guide care decisions for postmenopausal women with hormone receptor-positive breast cancer who may be at higher risk of late distant recurrence of disease in the absence of additional treatment.” Authors of the study reported that the ROR score, also known as the Prosigna Score, added prognostic information about the risk of 10-year distant recurrence beyond that provided by standard clinical-pathological variables in the analysis of all patients studied. In addition, the study reported that patients with Luminal A subtype (4.1 percent) had a lower risk of recurrence than those with the Luminal B subtype (12.9 percent) further supporting the biological differences between these groups1. “Few studies have addressed the prognostic value of molecular scores for late recurrence. These results add to the growing body of data supporting the clinical potential of the PAM50 gene signature and the Prosigna Breast Cancer Assay as a valuable prognostic tool for patients and their doctors,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. Results presented today at the 2013 San Antonio Breast Cancer Symposium build on a recently published paper in the Journal of the National Cancer Institute titled, “Factors predicting late recurrence for estrogen receptor positive breast cancer.” Authors of this 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.
1 The Prosigna Assay is not cleared by the U.S. Food and Drug Administration to report subtypes such as Luminal A and Luminal B.
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 will be 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: 1.
A prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (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.
A prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph 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 300 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 use of the Prosigna Assay to identify patients at risk of late distant disease recurrence. 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 the Prosigna Assay; 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. Investor Contact: Lynn Pieper of Westwicke Partners For NanoString Technologies [email protected] 415-202-5678 Media Contact: Maurissa Messier of Bioscribe Inc. For NanoString Technologies [email protected] 760-539-7417
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