Transferring a Quantitative Molecular Diagnostic Test to Multiple Real-Time Quantitative PCR Platforms

Quantitative gene expression assays are increasingly used for diagnosis and research, but are often restricted to specific instrumentation. We propose a robust technical and statistical framework that enables transferring of established real-time quantitative PCR assays across real-time quantitative PCR platforms without compromising analytical and clinical validity. The feasibility of our approach was tested on MammaTyper, an in？vitro diagnostic assay that quantifies breast cancer biomarkers and dichotomizes results according to cutoff points.