Decentral gene expression analysis: analytical validation of the Endopredict genomic multianalyte breast cancer prognosis test.

ABSTRACT:

Background

EndoPredict (EP) is a clinically validated multianalyte gene expression test to predict distant metastasis in ER-positive, HER2-negative breast cancer treated with endocrine therapy alone. The test is based on the combined analysis of 12 genes in formalin-fixed, paraffin-embedded (FFPE) tissue by reverse transcription-quantitative real-time PCR (RT-qPCR). Recently, it was shown that EP is feasible for reliable decentralized assessment of gene expression. The aim of this study was the analytical validation of the performance characteristics of the assay and its verification in a molecular-pathological routine laboratory.

Methods

Gene expression values to calculate the EP score were assayed by one-step RT-qPCR using RNA from FFPE tumor tissue. Limit of blank, limit

SUBMITTER: Kronenwett R 

PROVIDER: S-EPMC3534340 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature