Prosigna Shown to Predict Response to Chemotherapy
Prognostic Accuracy Confirmed in Comprehensive Nationwide Population Study
Second Decision Impact Study Confirms Prosigna Changes Physician Treatment Decisions
SEATTLE, June 1, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc., (Nasdaq:NSTG) a provider of life science tools for translational research and molecular diagnostic products, today highlighted the results from three important studies presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), which confirm the clinical significance of the Prosigna® Breast Cancer Assay based on the PAM50 gene signature. These studies provide additional evidence of Prosigna's ability to inform physician's treatment decisions by identifying high risk patients who may be responsive to chemotherapy and low risk patients who may be spared unnecessary therapy. Together, these studies substantially bolster the evidence for Prosigna's clinical utility in real world settings.
"The studies presented at ASCO have substantially strengthened the evidence for Prosigna's clinical utility," said Brad Gray, President and Chief Executive Officer of NanoString. "In combination with Prosigna's recent inclusion in the St. Gallen Breast Cancer Guidelines, these new data further demonstrate the power of Prosigna to physicians and payors, and support access to this important test for patients worldwide."
The first study supports Prosigna's clinical utility by verifying the ability of Prosigna to predict which patients respond to chemotherapy (Abstract #11049). The investigators demonstrated that within the population of HR+, HER2-, node-negative and node-positive (1-3 positive nodes) breast cancer patients, higher Prosigna ROR scores predicted increased response to a modern neoadjuvant chemotherapy regimen containing anthracyclines and taxanes (p=0.007).
"Multiple studies have now demonstrated that low risk patients identified by Prosigna can be spared chemotherapy," said Dr. Aleix Prat, Head Medical Oncology Department at Hospital Clínic, University of Barcelona and Principal Investigator of the study. "With this new study, we also have strong evidence that patients categorized by Prosigna as high risk are responsive to chemotherapy."
A second study, which involved the largest number of patient samples tested with Prosigna to date (n=2,749), yielded three separate abstracts. This retrospective-prospective study performed by the Danish Breast Cancer Study Group (DBCG) analyzed tissue samples and outcomes from all Prosigna-indicated Danish women diagnosed from 2000 to 2003, thus eliminating the selection or enrollment bias common in other population-based studies. Analysis of this comprehensive nationwide population demonstrated that in a real-world setting, Prosigna can:
- Reliably identify patients with low risk of recurrence who may be spared overtreatment with chemotherapy (Abstract #546)
- Identify a significant number of node-positive patients who have low risk of recurrence and may be spared chemotherapy (Abstract #513)
- Accurately predict risk of late recurrence, and therefore be utilized to identify patients who need, or more importantly may be spared, extended endocrine therapy (Abstract #544)
Finally, investigators from the West German Study Group evaluated the ability of the Prosigna Assay to influence treatment decisions by medical oncologists (Abstract #535). 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 18.2 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. This study replicates results from a similar study conducted in Spain and recently published by the Grupo Español de Investigación del Cáncer de Mama (GEICAM), Current Medical Research & Opinion, June 2015, Vol. 31, No. 6.
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, Turkey, South Africa and Hong Kong.
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 four or more positive nodes.
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 700 peer-reviewed publications. The nCounter Analysis System offers a cost-effective way to easily profile the expression of hundreds of genes, proteins, 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 also 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.
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 who will respond to chemotherapy and the clinical utility of Prosigna. 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.