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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.

Huntsman Cancer Institute Discovery Translates into Clinical FDA-Cleared Breast Cancer Test at ARUP Laboratories

The PAM50 breast cancer signature developed at the University of Utah and Huntsman Cancer Institute received FDA approval and will launch at ARUP Laboratories in Salt Lake City. The test utilizes gene expression data from 50 genes weighted together with clinical variables to generate a risk category and numerical score to assess a patient’s risk of distant recurrence at ten years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), Hormone Receptor-Positive (HR+) breast cancer.

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.

Study Published Showing Advantages of the PAM50 Gene Signature, the Basis for Prosigna, in Helping to Estimate Risk of Late Distant Recurrence in Postmenopausal Estrogen Receptor Positive Breast Cancer Patients

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 of the National Cancer Institute demonstrated that the PAM50 gene signature, which is the basis for the Prosigna™ Breast Cancer Prognostic Gene Signature Assay, provides important information to help estimate the risk of late distant recurrence in postmenopausal women with estrogen receptor positive (ER+) early-stage breast cancer. After comparing the PAM50 gene signature, the Oncotype DX® Breast Cancer Assay and the IHC4 score, the authors concluded that the PAM50 gene signature provided the strongest prognostic information regarding risk of distant recurrence five to 10 years following diagnosis in postmenopausal ER+ early-stage breast cancer patients treated with five years of endocrine therapy.

NanoString Technologies Receives FDA 510(k) Clearance for 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 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Prosigna™ Breast Cancer Prognostic Gene Signature Assay. Based on the PAM50 gene signature, Prosigna is the company’s first FDA-cleared in vitro diagnostic assay and uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay is performed using the nCounter® Dx Analysis System, which can be placed in qualified laboratories throughout the United States, empowering oncologists and pathologists to quickly and easily meet the testing needs of their breast cancer patients.

“Receipt of FDA 510(k) clearance for Prosigna marks a key milestone for NanoString and is an important step forward in the treatment of breast cancer. This achievement is a testament to the ongoing dedication and professionalism of our team, and the commitment of our collaborators,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “Prosigna illustrates our approach of using nCounter technology to translate genomic discoveries into powerful in vitro diagnostic products, and it represents a significant growth opportunity beyond our robust life sciences research business.”

The Prosigna Assay is intended for use as a prognostic indicator for distant recurrence-free survival at 10 years, and is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive (one to three positive nodes) hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment consistent with standard of care. For each patient, the Prosigna Assay reports the Prosigna Score (referred to as Risk of Recurrence Score, or ROR Score, in the scientific literature, including the TransATAC study recently published in the Journal of Clinical Oncology ) and a risk category based on both the Prosigna Score and nodal status. Node-negative patients are classified as low, intermediate or high risk, while node-positive patients are classified as low or high risk.

Other key features of the Prosigna Breast Cancer Prognostic Gene Signature Assay include:

  • All-in-one assay consumables, including RNA extraction kits, allowing laboratories to test as little as a single section of formalin-fixed paraffin embedded (FFPE) tumor tissue
  • High-throughput workflow allowing each nCounter Dx Analysis System to process up to 30 patient samples per eight hour work day
  • Automated generation of personalized full-color patient reports that can be quickly and easily shared electronically with ordering oncologists

Bruce Seeley, Senior Vice President & General Manager of Diagnostics of NanoString Technologies commented: “We believe that the compelling clinical data, clear patient reporting, and unique delivery model position Prosigna for success in the U.S. market. By integrating the Prosigna Assay into existing laboratory workflows, we are offering physicians and patients seamless and timely access to clinical insights and a powerful tool that can aid in making more informed treatment decisions.”

Prosigna-enabled nCounter Dx Analysis Systems are expected to be available for placement in high-complexity Clinical Laboratory Improvement Amendments (CLIA) certified laboratories late in the fourth quarter of 2013. Prosigna testing services are expected to be available through qualified U.S. clinical laboratories beginning in the first quarter of 2014.

Source: NanoString Technologies