Study Published in The Journal of Clinical Oncology Demonstrates Advantages of NanoString's ProsignaTMBreast Cancer Assay
Authors Conclude that PAM50-based Assay Provides More Prognostic Information than Oncotype DX®with Better Differentiation of Intermediate and High Risk Groups
SEATTLE--(BUSINESS WIRE)-- NanoString Technologies, Inc. (NAS: NSTG) , a provider of life science tools for translational research and molecular diagnostic products, today announced that the TransATAC clinical validation study for its Prosigna Breast Cancer Prognostic Gene Signature Assay, which is based on the PAM50 gene signature, was published in the Journal of Clinical Oncology (JCO)1. This study, portions of which were initially presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium, evaluated the ability of three breast cancer tests to predict risk of distant recurrence after endocrine therapy in postmenopausal women with hormone receptor-positive (HR+) early-stage breast cancer. The authors of the study concluded that the PAM50-based assay provides more prognostic information in endocrine treated patients with HR+ node negative disease than Oncotype DX®, with better differentiation of intermediate and high-risk groups.
The study included 1,017 samples from the landmark ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial of postmenopausal women with HR+ early-stage breast cancer treated with five years of endocrine therapy. The study was performed on RNA extracted from tumor samples by Genomic Health, Inc. for validation of the Oncotype DX® Breast Cancer Assay. The goals of the TransATAC study were to determine if the PAM50 gene signature added prognostic information to clinical-pathological variables and to compare the performance of the PAM50 risk of recurrence (ROR) score, the Oncotype DX recurrence score (RS), and the IHC4 score, derived from immunohistochemical assessment of ER, PR, HER2 and Ki67 genes, in indicating risk of distant recurrence after endocrine therapy. All primary and secondary endpoints of the study were met.
Authors of the study reported that the PAM50 ROR score added prognostic information about the risk of 10-year distant recurrence in addition to that provided by standard clinical-pathological variables in the analysis of all patients studied (p < 0.001). Similar results were achieved in all three prospectively defined clinically important subsets of patients: node-negative (p < 0.001), node-positive (p = 0.002), and HER2-negative (p < 0.001). In addition, the study reported that patients with Luminal A subtype had a lower risk of recurrence than those with the Luminal B subtype further supporting the biological differences between these groups.
The authors also concluded that the PAM50 ROR score provided more prognostic information than the widely used Oncotype DX RS. Compared to Oncotype DX RS, PAM50 ROR score categorized fewer patients as intermediate-risk and more as high-risk when using prospectively defined risk cutoffs for low, intermediate and high risk of <10%, 10% to 20% and >20% estimated risk of recurrence, respectively. Moreover, the authors concluded that the PAM50 ROR score provided at least as much information as the IHC4 and may provide more information than IHC4 in the node negative/HER2 negative patient group.
"The publication of the TransATAC study is an important milestone in our ongoing effort to enable genomic testing for breast cancer in local laboratories worldwide," said Brad Gray, President and Chief Executive Officer of NanoString Technologies. "We look forward to discussing the results and conclusions of this study with oncologists, pathologists, and payers in the European Union and other countries that recognize the CE Mark, as we continue with our commercial launch in those regions."
The TransATAC clinical validation study, titled "Comparison of PAM50 risk of recurrence (ROR) score with Oncotype DX and IHC4 for predicting risk of distant recurrence after endocrine therapy" was published online in JCO, and can be found at: http://jco.ascopubs.org/content/early/2013/06/25/JCO.2012.46.1558.abstract.
About the Prosigna™Breast Cancer Prognostic Gene Signature Assay
Prosigna assesses risk of recurrence (ROR) in postmenopausal women with early-stage hormone receptor positive (HR+) breast cancer. The Prosigna Assay has received a CE mark 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; it is pending 510(k) clearance with the Food and Drug Administration and is not available for sale in the United States.
Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay provides a subtype classification based on the fundamental biology of an individual's breast tumor (referred to as intrinsic subtyping), and a prognostic score (referred to as the ROR score). The ROR score estimates the probability of cancer recurrence within 10 years in postmenopausal women with HR+ early-stage breast cancer who have been treated with endocrine therapy alone. The Prosigna Assay was validated in two clinical studies with more than 2,400 patient samples and results were presented at the 2011 and 2012 San Antonio Breast Cancer Symposiums.
The Prosigna Assay requires minimal hands-on time and can be offered to healthcare professionals in qualified pathology laboratories, in the European Union and other countries that recognize the CE Mark and in which Prosigna is registered, empowering oncologists and pathologists to manage the diagnostic evaluation of breast cancer patients locally and using the laboratory infrastructure already in place. The Prosigna Assay runs on NanoString's proprietary nCounter Analysis system, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision. In North America, the nCounter Analysis System is not intended for diagnostic use, but is available for "Research Use Only".
For more information, please visit www.prosigna.com.
About NanoString Technologies, Inc.
NanoString Technologies is a provider of 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 220 peer-reviewed publications, has also now been applied to diagnostic use in the European Union. The 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. 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 kit to be marketed through the company's recently formed diagnostics business.
The nCounter Analysis System is available for "Research Use Only" in North America. For more information, please visit www.nanostring.com.
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.
1 Dowsett, M., Sestak, I., Lopez-Knowles, E. et al (2013) Comparison of PAM50 risk of recurrence (ROR) score with Oncotype Dx and IHC4 for predicting risk of distant recurrence after endocrine therapy Journal of Clinical Oncology online, http://jco.ascopubs.org/content/early/2013/06/25/JCO.2012.46.1558.abstract.
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