SEATTLE--(BUSINESS WIRE)--NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that the U.S. Food and Drug Administration (FDA) has cleared a labeling update for the Prosigna® Breast Cancer Gene Signature Assay. The labeling update is derived from the analysis of data by researchers from the Austrian Breast and Colorectal Cancer Study Group Trial 8 (ABCSG-8), who previously reported that the Prosigna Assay accurately assessed the probability of distant recurrence in postmenopausal women with Estrogen Receptor-Positive (ER+) early-stage breast cancer.
The Prosigna FDA labeling now provides greater insight into observed risk of distant recurrence five to 10 years after diagnosis, which includes:
- The identification of low risk node-negative patients, who have 1.3 percent probability of distant recurrence between years five and 10.
- Additionally, the identification of a low-risk portion of node-positive patients who have 3.7 percent probability of distant recurrence between years five and 10.
“We are pleased that the Prosigna labeling has been updated to highlight that the Prosigna Score provides insight into the probability of distant recurrence events in the first five years, while patients are receiving endocrine therapy, and between years five and 10 after diagnosis, following completion of endocrine therapy,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “These new data enhance the utility of the Prosigna Assay and support its ability to provide a greater level of valuable information for clinicians and their patients.”
“As we have previously reported in a paper published earlier this year in Clinical Cancer Research, it’s essential for the oncology community to identify tools that will more accurately differentiate the risk of breast cancer patients to determine who remain at a low probability of distant recurrence beyond five years after diagnosis,” said Michael Gnant, M.D., Professor at the Medical University of Vienna in Austria. “These data help demonstrate the potential for the PAM50-based Prosigna Assay to inform both the use of adjuvant chemotherapy and the use of extended adjuvant endocrine therapy based on a risk of recurrence score.”
The Clinical Cancer Research (CCR) paper, titled “The PAM50 Risk-of-Recurrence Score Predicts Risk for Late Distant Recurrence after Endocrine Therapy in Postmenopausal Women with Endocrine-Responsive Early Breast Cancer” was first released online on February 11, 2014 and then printed in the March 1, 2014 issue of CCR.
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 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 or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 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. 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 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.
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 distant disease recurrence 5-10 years after diagnosis and the potential of Prosigna to inform both the use of adjuvant chemotherapy and the use of extended adjuvant endocrine therapy based on a single risk score. 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 Prosigna; 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, nCounter, and Prosigna are registered trademarks or trademarks of NanoString Technologies, Inc. in various jurisdictions.