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 tumour 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.
Your global partner for biomarker discovery, development & commercialisation.
We offer a range of genomics platform and chemistry options, alongside expert data sciences support and a full sample management service.
Clinical Trial Assays
Comprehensive development, validation & delivery service for research and clinical use assays from our global clinical laboratories in USA, Europe and APAC.
A collaborative Companion Diagnostic partnership approach with a deep understanding of client needs. We offer CDx development, manufacture & commercialisation services.