Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens

摘要: NanoString’s Prosigna™ Breast Cancer Prognostic Gene Signature Assay is based on the PAM50 gene expression signature. The test outputs a risk of recurrence (ROR) score, category, and intrinsic subtype (Luminal A/B, HER2-enriched, Basal-like). studies described here were designed to validate analytical performance nCounter Analysis System across multiple laboratories. Analytical precision was measured by testing five breast tumor RNA samples 3 sites. Reproducibility replicate tissue sections from 43 FFPE blocks sites following independent pathology review at each site. input range validated comparing assay results extremes specified nominal level. Interference evaluated including non-tumor into test. standard deviation (SD) less than 1 ROR unit within study total SD 2.9 units reproducibility study. scores for inputs same as those stable in presence moderate amounts surrounding (<70% area). Prosigna has been using specimens clinical