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NanoString Technologies Receives Canadian Market Approval for its Prosigna Breast Cancer Prognostic Gene Signature Assay

NanoString Technologies, Inc., (NASDAQ:NSTG) a provider of life science tools for translational research and molecular diagnostic products, recently announced that it has received a Class III Medical Device License from Health Canada, clearing the company to market its Prosigna® Breast Cancer Prognostic Gene Signature Assay for assessing a woman’s 10-year risk of distant recurrence and accurately identifying the intrinsic biologic subtype of the tumor.

Newly Published Analytical Validation Study Shows Precision and Reproducibility of PAM50-Based Prosigna Breast Cancer Assay in Multiple Clinical Testing Laboratories

NanoString Technologies, Inc., (NASDAQ:NSTG) a provider of life science tools for translational research and molecular diagnostic products, recently announced that a study published online in the journal BMC Cancer demonstrates the analytical validity of the PAM50-based Prosigna™ Breast Cancer Prognostic Gene Signature Assay. Based on highly concordant results across multiple clinical laboratory sites, technicians, and manufacturing lots of Prosigna reagents, the authors concluded that the study provides a strong body of evidence supporting the decentralized use of the Prosigna Assay on the nCounter Dx Analysis System as a prognostic tool for the risk of recurrence (ROR) in selected breast cancer patients.

PAM50-Based Prosigna Breast Cancer Assay Helps to Identify Patients at Risk of Late Distant Recurrence in a Combined Analysis of 2,137 Patients

NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, recently announced new results from a combined analysis of the Austrian Breast & Colorectal Cancer Study Group 8 (ABCSG-8) and Trans-Arimidex, Tamoxifen, Alone or in Combination (TransATAC) studies. These results, which evaluated samples from 2,137 patients, suggest that the PAM50-based Prosigna™ Breast Cancer Prognostic Gene Signature Assay may help identify women with late distant recurrence after five years of endocrine treatment. Using the Prosigna Assay, the study investigators classified patient tumors by subtype and found that patients with Luminal B subtype have three times higher risk of late distant recurrence than patients with Luminal A subtype tumors. Results were presented at the 2013 San Antonio Breast Cancer Symposium.

ASCO and the CAP Release Updated Guideline on HER2 Testing in Breast Cancer

The American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) recently issued a joint, updated guideline aimed at improving the accuracy and reporting of human epidermal growth factor receptor 2 (HER2) testing in patients with invasive breast cancer. The guideline update is based on a systematic review of medical research literature, providing oncologists and pathologists with detailed recommendations for how to test for HER2 overexpression, interpret the results, and recommend HER2-targeted therapies. The guideline, originally issued in 2007, is being published in ASCO’s Journal of Clinical Oncology (JCO) and the CAP’s Archives of Pathology & Laboratory Medicine. The joint guideline was prepared by an ASCO/CAP Update Committee consisting of experts in breast cancer and cancer biomarkers.

Genomic Health Announces Presentation of Oncotype DX Studies Reinforcing Value of Tests in Guiding Treatment for Multiple Cancers

Genomic Health, Inc. (Nasdaq: GHDX) recently announced results from four studies highlighting the value of its Oncotype DX® tests for optimizing treatment for patients with breast and colon cancer. Three new decision impact studies – including the company’s first international decision impact study in colon cancer and additional evidence for the Oncotype DX breast cancer test’s significant impact on breast cancer treatment decisions in the United Kingdom (UK) – were among data presented at the European Cancer Congress 2013 in Amsterdam. The results were presented on the heels of the recent National Institute for Health and Care Excellence (NICE) guidance announcement that recommended the use of Oncotype DX “as an option to help clinicians decide whether to prescribe chemotherapy in people with early breast cancer.”