On February 09, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported that the updated American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Clinical Practice Guideline on the appropriate use of breast tumor biomarker assay results recommends the use of the Prosigna Breast Cancer Prognostic Gene Signature Assay (PAM50) to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer with known hormone receptor and HER2 status (Press release, NanoString Technologies, FEB 9, 2016, View Source [SID:1234509010]). The Prosigna assay was one of only two such assays to receive a "high" rating of evidence quality together with a "strong" recommendation.
"Prosigna’s inclusion in the ASCO (Free ASCO Whitepaper) Clinical Practice Guideline, specifically for use in guiding decisions on adjuvant systemic therapy for women with early stage breast cancer, places Prosigna on equal footing with the Oncotype DX test," said Brad Gray, President and Chief Executive Officer of NanoString Technologies. "This is the sixth major breast cancer treatment guideline to include Prosigna in the past twelve months, and it further strengthens our case for reimbursement and market adoption."
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The ASCO (Free ASCO Whitepaper) Clinical Practice Guideline provides evidence-based recommendations based on a comprehensive review and analyses of the relevant literature for each recommendation. The Guideline states that if a patient has hormone receptor-positive, HER2-negative (node-negative) breast cancer, the clinician may use the PAM50 (Prosigna) risk of recurrence (ROR) score, known as the Prosigna Score in the United States, in conjunction with other clinicopathologic variables, to guide decisions on adjuvant systemic therapy.
"We applaud the rigorous scientific methodology and transparency that the ASCO (Free ASCO Whitepaper) multidisciplinary expert breast cancer panel applied in reviewing and weighing the available scientific evidence," said Alessandra Cesano, M.D., Ph.D., Chief Medical Officer of NanoString. "By focusing on the clinical utility of sparing women unnecessary chemotherapy, the Committee has helped future breast cancer patients avoid the risk of fatal, life-threatening, or permanently changing toxicities."
The Guideline, together with additional information including details of the methodology and review of the scientific literature, is available at: View Source
About the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analysis System
The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma.
The Prosigna Assay requires minimal hands-on time and runs on NanoString’s proprietary nCounter Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision.
The nCounter Dx Analysis System is a highly automated and easy-to-use platform that utilizes a novel digital barcoding chemistry to deliver high precision multiplexed assays. The system is available in the multi-mode FLEX configuration, which is designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Breast Cancer Assay and, when operated in the "Life Sciences" mode, process translational research experiments and multiplexed assays developed by the laboratory.
In the United States, the Prosigna Assay is available for diagnostic use when ordered by a physician. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as Canada, Israel, Australia, New Zealand and Hong Kong.
In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:
(1) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes.
For more information, please visit www.prosigna.com.