NanoString Technologies, a provider of life science tools for translational research and molecular diagnostic products, has announced the availability of the nCounter Dx Analysis System for high-complexity, CLIA-certified laboratories. The nCounter Dx Analysis System is the only platform 510(k) cleared by the FDA to run the Prosigna Prognostic Breast Cancer Gene Signature Assay. The FLEX configuration offered on the nCounter Dx Analysis System supports other translational research applications, and facilitates the ability of laboratories to develop their own assays.

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 nCounter Dx Analysis System 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, allowing oncologists and pathologists to quickly and easily meet the testing needs of their breast cancer patients for determining the risk of distant disease recurrence.

The 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 and, when operated in the “Life Sciences” mode, process translational research experiments and multiplexed assays developed by the clinical laboratory. The nCounter Elements General Purpose Reagents (GPRs) offered by NanoString provide further flexibility by enabling laboratories to develop their own gene expression, copy number variation and gene fusion signatures.

When used together, they offer high-throughput workflow allowing each nCounter Dx Analysis System to perform the Prosigna Assay on up to 30 patient samples per eight hour work day and obtain assay results in as little as two days; ready-to-use Prosigna Assay consumables, including RNA extraction kits, allowing laboratories to test as little as a single section of formalin-fixed paraffin embedded (FFPE) tumor tissue; and automated generation of personalized full-color Prosigna Assay patient reports that can be quickly and easily shared electronically with ordering oncologists, and which includes the patient’s Prosigna Score and risk category.