NanoString Technologies has announced the release of its nCounter Dx Analysis System for high-complexity, CLIA-certified laboratories.  The system is the only one in the country currently 510(k) certified by the United States Food and Drug Administration to run the Prosigna Prognostic Breast Cancer Gene Signature Assay, an in vitro diagnostic assay that relies on the gene expression profile of breast cancer tissue cells to evaluate a patient’s risk of distant recurrence of the disease.  Laboratories can also use the nCounter system to develop their own assays.

The nCounter system is available in a multi-mode FLEX configuration and uses a novel digital barcoding chemistry to offer multiplexed assays. When switched to a “Life Sciences” mode, it also allows laboratories to process their own translational research experiments. When integrated with the system, the Prosigna assay can be performed on up to 30 patient samples per day, obtaining results within 48 hours. The platform also generates full-color reports that include a patient’s Prosigna score and risk category.

“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,” said Brad Gray, president and chief executive officer for NanoString Technologies. The nCounter system can now be purchased or rented in the United States and countries that accept the CE mark. Prosigna testing services are expected to be available from qualified US laboratories starting in early 2014.