NanoString to begin clinical development program for Breast Cancer Intrinsic Subtyping Assay

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."