Analytical validation of a prognostic prostate cancer gene expression assay using formalin fixed paraffin embedded tissue
There is a clear need for assays that can predict the risk of metastatic prostate cancer following curative procedures. Importantly these assays must be analytically robust in order to provide quality data for important clinical decisions. DNA microarray based gene expression assays measure several analytes simultaneously and can present specific challenges to analytical validation. This study describes the analytical validation of one such assay designed to predict metastatic recurrence in prostate cancer using primary formalin fixed paraffin embedded tumor material.
The Metastatic Assay was found to be highly reproducible and precise. In conclusion, the studies demonstrated an acceptable analytical performance for the assay and support its potential use in the clinic.