NanoString Technologies has introduced the first commercial IVD for its nCounter diagnostic platform, the company announced. Launched in the EU and Israel, the Prosigna breast cancer prognostic gene signature assay classifies a breast tumor based on intrinsic subtyping and a prognostic score. The score, referred to as risk of recurrence (ROR), estimates the probability that cancer will recur within 10 years in post-menopausal women with hormone receptor–positive breast cancer in its early stage. It is designed for patients who have been treated with endocrine therapy only.
The Prosigna assay was validated with two clinical studies that involved more than 2400 patient samples and results, according to NanoString. Based on the PAM50 gene signature discovered by Charles Perou and colleagues, the assay is designed to minimize hands-on involvement and to enable oncologists to evaluate patients locally, the company says. The nCounter platform enables sensitive and precise profiling of hundreds of samples simultaneously, according to NanoString. The system is available only for research in the United States at the moment.
Calling the launch “a significant milestone” for the company, Brad Gray, president and CEO, says Prosigna eliminates “the need to send precious samples to a centralized reference lab that may be overseas.” Gray discussed the nCounter platform, his decision to accept the head job at the Seattle-based life science company, NanoString’s “translational” technology, and related topics in this April 2011 Q&A with MX:Medtech Executive