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 US Food and Drug Administration (FDA) to run the Prosigna prognostic breast cancer gene signature assay.

For clinical laboratories that value flexibility, 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.

NanoString will showcase the new nCounter Dx Analysis System and its advanced capabilities at this week’s annual Association for Molecular Pathology (AMP) conference in Phoenix, Arizona.

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 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 US and countries that accept the CE Mark, empowering 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 nCounter Dx analysis 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 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.

NanoString Technologies president and CEO Brad Gray noted the company has received significant interest from laboratories seeking to perform the Prosigna breast cancer assay as well as run genomic assays that they have developed independently.

"With the nCounter Dx Analysis System’s FLEX configuration, the Prosigna Breast Cancer Assay, and with our recently launched nCounter Elements GPRs, we have a compelling suite of products for these laboratories.

"We expect the versatility of this offering to help drive the adoption of the Prosigna Breast Cancer Assay and be particularly appealing to high-complexity CLIA laboratories in major U.S. cancer centers," Gray added.

When used together, the nCounter Dx analysis system and prosigna breast cancer prognostic gene signature assay provide the following key features:

– 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

– 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

The nCounter Dx analysis system is now available for purchase or through reagent rental arrangements in the US and countries that accept the CE Mark.

Prosigna testing services are expected to be available from qualified laboratories in the US beginning in the first quarter of 2014.