NanoString Technologies, Inc., has announced the availability of the nCounter Dx Analysis System for high-complexity, CLIA-certified laboratories. The nCounter Dx Analysis System is 510(k) cleared by the U.S. Food and Drug Administration to run the Prosigna Prognostic Breast Cancer Gene Signature Assay. NanoString is showcasing the nCounter Dx Analysis System at this week’s Association for Molecular Pathology (AMP) conference in Phoenix.
The nCounter Dx Analysis System is an automated platform that supports the Prosigna Breast Cancer Prognostic Gene Signature Assay, an in vitro diagnostic assay that uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease. Using the nCounter Dx Analysis System, the Prosigna Assay can be performed in qualified clinical laboratories throughout the U.S. and countries that accept the CE Mark.
The nCounter Dx Analysis System is available in the multi-mode FLEX configuration, designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Breast Cancer Assay. The nCounter Elements General Purpose Reagents offered by NanoString enable laboratories to develop their own gene expression, copy number variation, and gene fusion signatures.
When used together, the nCounter Dx Analysis System and Prosigna Breast Cancer Prognostic Gene Signature Assay provide high-throughput workflow; ready-to-use consumables, including RNA extraction kits; and automated generation of personalized full-color Prosigna Assay patient reports that can be shared electronically with ordering oncologists and which include the patient’s Prosigna Score and risk category. Learn more about the nCounter Dx Analysis System.