Prosigna®, produced by the nanoString company, uses the PAM50 gene marker to transform tumor biology into a personalized prognostic ROR (Risk of Recurrence) score for breast cancer-diagnosed individuals. Prosigna® is suitable for in vitro diagnostic use in hormone receptor positive patients with 0-3 lymph node positivity.

The Prosigna® Breast Cancer Prognostic Gene Signature Test on the nCounter® Dx Analysis System was approved by the FDA (U.S. Food and Drug Administration) in September 2013. The test also received the IVD-CE mark in Europe in 2012, which indicates that it can be used for diagnostic purposes.

Expression of the Pam50 genes is determined in a single reaction without the need for amplification. Gene expression profile of the patient’s tumor is compared to known breast cancer intrinsic subtypes by applying the algorithm developed by NanoString, using experimental validation studies. With this algorithm, not only an individualized Prosigna ROR Score is generated by the combination of the proliferation score and the tumor size, but also the breast cancer subtype is reported. The Prosigna ROR Score is a numeric value in the range of 0-100 and it is related to the probability of recurrence over a period of 10 years.

The fully automated and easy-to-use nCounter®-based Prosigna® test ensures rapid and accurate analysis of breast cancer gene expression profile, produces precise, reproducible prognostic information in local laboratories and helps healthcare professionals to continue with informed treatment decisions.