NanoString Technologies, Inc., a provider of life science tools for translational research and molecular diagnostic products, announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for breast cancer have been updated to acknowledge that its PAM50 gene signature, commercialised as the Prosigna Breast Cancer Prognostic Gene Signature Assay, has been clinically validated for prediction of prognosis.
"In line with our expectations, Prosigna is now recognised in the NCCN guidelines as providing clinically validated prediction of a woman's risk of breast cancer recurrence," said Brad Gray, president and chief executive officer of NanoString Technologies.
"Discussion of Prosigna in the NCCN guidelines following our first submission is an important achievement, and we believe it establishes a solid foundation upon which we can continue to build the market for Prosigna."
The NCCN guidelines are an authoritative source of information to help healthcare professionals make informed decisions about cancer care, and are often used by public and private payors to establish coverage policies. Prosigna's acknowledgement in the NCCN guidelines resulted from a review by a multidisciplinary panel of experts from NCCN member institutions, and is based on requests and clinical data submitted in June 2014. The newly updated guidelines (version 3.2015) appear on the NCCN website.
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 utilises 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 tumour 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 utilises 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 recognise the CE Mark, as well as Canada, Israel, Australia, New Zealand, Turkey, South Africa and Hong Kong.
In the US, 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.