Analytical validation of HER2DX genomic test for early-stage HER2-positive breast cancer.

ABSTRACT:

Background

HER2DX, a multianalyte genomic test, has been clinically validated to predict breast cancer recurrence risk (relapse risk score), the probability of achieving pathological complete response post-neoadjuvant therapy (pCR likelihood score), and individual ERBB2 messenger RNA (mRNA) expression levels in patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. This study delves into the comprehensive analysis of HER2DX's analytical performance.

Materials and methods

Precision and reproducibility of HER2DX risk, pCR, and ERBB2 mRNA scores were assessed within and between laboratories using formalin-fixed paraffin-embedded (FFPE) tumor tissues and purified RNA. Robustness was appraised by analyzing the impact of tumor cell conten

SUBMITTER: Marin-Aguilera M 

PROVIDER: S-EPMC10937240 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature