13P Analytical Validation of HER2DX Test for Early-Her2+ Breast Cancer

HER2DX is a genomic test for early HER2+ breast cancer clinically available since January 2022 as a Laboratory Developed Test. Based on the expression of 27 genes (nCounter) plus tumor and nodal staging, it predicts the risk of relapse (risk-score), the probability of achieving a pathological complete response (pCR-score), and the individual levels of ERBB2 expression (ERBB2-score). Here, we report the analytical validation of HER2DX performed in a central laboratory (CLab) having as a reference the development lab (DLab).