SEATTLE--(BUSINESS WIRE)--NanoString Technologies, Inc., a privately held provider of life science tools for translational research and molecular diagnostic products, today announced it has launched its first commercial in vitro diagnostic product, the Prosigna™ Breast Cancer Prognostic Gene Signature Assay for the nCounter® diagnostic system in the European Union (EU) and Israel.
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 risk of recurrence, or ROR, score). The ROR score estimates the probability of cancer recurrence by 10 years in post-menopausal women with hormone receptor-positive 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 Symposium.
The Prosigna assay requires minimal hands-on time and can be offered through qualified pathology laboratories, empowering oncologists and pathologists to manage the diagnostic evaluation of breast cancer patients locally. The Prosigna assay runs on NanoString’s proprietary nCounter system, which offers a simple, reproducible and cost-effective way to profile hundreds of targets simultaneously with high sensitivity and precision. The nCounter Analysis System is currently available for “Research Use Only” in North America.
“Prosigna provides physicians and their patients access to analytically and clinically validated genomic information that can impact important treatment decisions, without the need to send precious samples to a centralized reference lab that may be overseas,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “Our launch in the European Union and Israel marks the beginning of our efforts to market Prosigna globally. This is a significant milestone for NanoString as we launch our commercial diagnostics business and work toward additional regulatory marketing authorizations.”
J. Wayne Cowens, M.D., Chief Medical Officer for NanoString Technologies added: “I would like to extend my heartfelt thanks to the investigators and patients who participated in the two pivotal trials for Prosigna. We look forward to making Prosigna available to the many breast cancer patients in need throughout the European Union and Israel.”
About the Prosigna™ Breast Cancer Prognostic Gene Signature Assay
The Prosigna™ Breast Cancer Prognostic Gene Signature Assay is indicated for risk assessment in early-stage post-menopausal breast cancer patients with hormone receptor-positive (HR+) stage I or II disease. It 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 risk of recurrence, or ROR, score). The ROR score estimates the probability of cancer recurrence by 10 years in post-menopausal women with hormone receptor-positive early-stage breast cancer who have been treated with endocrine therapy alone.
The Prosigna assay is approved for use by healthcare professionals in the European Union and Israel; it is not available in North America. For more information, please visit www.prosigna.com.
About NanoString Technologies, Inc.
NanoString Technologies is a privately held provider of life science tools for translational research and developer of 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 180 peer-reviewed publications, has also now been optimized as a diagnostic platform. 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 currently 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.