PAM50-based gene signature test, for EU and Israel, 5/13:86

NanoString Technologies has launched its first commercial IVD product, the Prosigna breast cancer prognostic gene signature assay for the nCounter diagnostic system, in the European Union and Israel.

Based on the PAM50 gene signature initially discovered by Charles Perou, PhD, and colleagues, the Prosigna assay provides a subtype classification based on the biology of an individual’s breast tumor (intrinsic subtyping), and a prognostic score (risk of recurrence, or ROR, score). The score estimates the probability of cancer recurrence by 10 years in postmenopausal women with hormone receptor-positive early-stage breast cancer who have been treated with endocrine therapy alone. The assay was validated in two clinical studies with more than 2,400 patient samples, and results were presented at the 2011 and 2012 San Antonio Breast Cancer Symposium.

The Prosigna assay runs on NanoString’s proprietary nCounter system, which is available for research use only in North America. The assay is not available in North America.

NanoString Technologies, 888-358-6266