NanoString Embarks on First in Series of Clinical Studies for Breast Cancer Intrinsic Subtyping Assay

Study to Evaluate Disease Prognosis Using NanoString’s PAM50-based Assay on the TransATAC Sample Set

SEATTLE--(BUSINESS WIRE)-- NanoString Technologies, Inc., a privately held provider of life science tools for translational research and developer of molecular diagnostics, today announced that it is initiating the first in a series of studies to evaluate the clinical utility of the NanoString Breast Cancer Intrinsic Subtyping Assay. The initial investigation will utilize samples from the TransATAC study to evaluate whether the assay, which is based on the PAM50 gene signature, can quantitate the probability of cancer recurrence in individual post-menopausal women with hormone receptor-positive, early stage breast cancer (ESBC) who have been treated with hormonal therapy.

The clinical development program for NanoString’s Breast Cancer Intrinsic Subtyping Assay is designed to support both its regulatory clearance and its incorporation into worldwide breast cancer treatment guidelines. The study of the TransATAC patient population is the first in this program and will be performed on approximately 1,000 samples, which have already been used to study the performance of other diagnostic tests in post-menopausal women with hormone receptor-positive ESBC.

TransATAC is a translational study group that has used the tissue and data from the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial to study the molecular characteristics of tumors in patients with ESBC. Mitch Dowsett, Ph.D., head of the Academic Department of Biochemistry at the Royal Marsden NHS Trust and Professor of Translational Research at the Breakthrough Research Centre at the Institute of Cancer Research, is a member of the TransATAC study group and the lead investigator collaborating with NanoString on this study.

“Based on the large body of evidence supporting the clinical validity of the PAM50 gene signature and the distributable nature of the nCounter platform, we have decided both to independently evaluate the performance NanoString’s assay in the TransATAC patient population and to compare the PAM50 results on disease prognosis to those of currently available approaches,” said Dr. Dowsett.

NanoString announced in December 2010 that it had secured an exclusive worldwide license for the PAM50 gene signature from Bioclassifier, LLC to develop in vitro diagnostic and research products for breast cancer on its nCounter® Analysis System. The PAM50 gene signature provides a subtype classification based on the fundamental biology of an individual’s breast tumor (referred to as intrinsic subtyping), which can be used to develop a prognostic score. This subtyping information cannot be reliably gained through other currently available diagnostic tests and may provide clinically useful information for a broad range of breast cancers, including classification of tumors from patients with estrogen receptor-negative tumors.

“We have been extremely pleased by the positive response of the breast cancer community to our plans to develop a globally distributable breast cancer test based on the PAM50 gene signature,” said Wayne Cowens, M.D., Chief Medical Officer of NanoString Technologies. “The ATAC study was pivotal in advancing the treatment of women with ESBC; we are honored that the TransATAC investigators have agreed to use their valuable samples to evaluate the clinical performance of our assay.”

Following regulatory approvals, the company intends to make the NanoString Breast Cancer Intrinsic Subtyping Assay available on the nCounter platform to pathology laboratories and medical centers worldwide. The nCounter Analysis System is a fully automated digital detection and counting system with a very simple workflow. The assay kits contain all the reagents and consumables required to conduct an experiment. Its ability to analyze small samples and its compatibility with a variety of sample types (including Formalin-Fixed, Paraffin-Embedded tissue) make the system useful for exploring a broad range of problems in translational medicine. In addition to gene expression assays, NanoString provides assays for copy number variation and miRNA analysis. The nCounter Analysis System is currently available for Research Use Only.

More information is available at www.NanoString.com.

About NanoString Technologies, Inc.

NanoString Technologies is a privately held provider of life science tools for translational research and developer of molecular diagnostics. The company’s nCounter® Analysis System is the first and only technology platform to deliver highly multiplexed, direct profiling of individual molecules in a single reaction without amplification. The nCounter Analysis System offers a cost-effective way to easily profile hundreds of gene transcripts, copy number variations, or miRNAs 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. NanoString is also developing the technology for use in molecular diagnostics.

The nCounter platform is for Research Use Only. Not for use in diagnostic procedures.



CONTACT:

for NanoString Technologies, Inc.
Nicole Litchfield, 415-793-6468
[email protected]

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