NanoString Technologies Inc., a provider of life science tools for translational research and molecular diagnostic products, recently announced nationwide availability of its Prosigna breast cancer prognostic gene signature assay beginning in the first quarter of 2014. The assay provides treated patients with timely access to a genomic assessment of a tumor’s underlying biology and risk of distant recurrence.
Initial adopters of the assay include major national diagnostic organizations ARUP Laboratories, Laboratory Corporation of America (LabCorp), and Quest Diagnostics. NanoString also announced that laboratories at the University of Alabama at Birmingham Comprehensive Cancer Center and the University of North Carolina Lineberger Comprehensive Cancer Center will be among the initial wave of facilities to offer the Prosigna assay in 2014.
“We look forward to working closely with our clinical laboratory and cancer center partners, and believe these collaborations will provide a solid foothold in the breast cancer genomic assay market,” said Brad Gray, NanoString president and CEO. “These laboratories collectively serve the pathology testing needs of a substantial portion of breast cancer patients throughout the United States. In the months ahead, we plan to coordinate closely with these laboratories so they can successfully provide locally accessible and clinically important insights from breast tumor genomics.”
The Prosigna assay provides a risk category and numerical score for assessing 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, the Prosigna assay is an in vitro diagnostic that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score that expresses a patient’s risk of distant recurrence. 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.
“This is the next generation of diagnostics, which embraces both the molecular and anatomic features of a tumor to provide a more accurate estimate of risk,” said Philip Bernard, MD, medical director for ARUP Laboratories and an associate professor of pathology at the University of Utah.
According to NanoString, the Prosigna assay requires minimal hands-on time and runs on the company’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.
National diagnostic laboratories adopting the Prosigna assay commented on the new offering:
“LabCorp is pleased to be among the first laboratories to offer the Prosigna assay,” stated Mark Brecher, MD, LabCorp chief medical officer. “Prosigna provides physicians and their patients a new and important diagnostic tool, in conjunction with other clinical and pathological factors, to help monitor and treat breast cancer recurrence.”
“We are pleased to form this relationship with NanoString,” said Gerald LaFlamme, general manager for the oncology business of Quest Diagnostics. “The Prosigna assay will extend our capabilities in breast cancer and provide an important new option for women.”
In the United States, Prosigna is indicated for use in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:
- 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.
- A prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with hormone receptor-positive (HR+), lymph node-positive (one to three positive 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.
The Prosigna assay is not intended for diagnosis, to predict or detect response to therapy, or to help select the optimal therapy for patients. The assay will be available for diagnostic use when ordered by a physician in the United States. The 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 and in which Prosigna is registered.
For more information, visit NanoString Technologies.
