Gene expression profiles that provide clinical utility have been developed in the last decade. However, only a handful are currently available for broad clinical use through commercial enterprises. Once a test does enter the clinical setting it is imperative to get the correct answer even under conditions of varying quality of sample input. In the transition phase of the development of a commercial available test there are a number of requirements that need to be met. In particular, for a gene expression microarray test using a multiple gene index as read-out, a customized array including control systems needs to be designed, validated and shown to be reproducible, robust, accurate and stable over time. In addition, regulatory approval is needed. This chapter describes all important critical steps being met for the implementation of a multi-marker microarray (MammaPrint®) as a routine diagnostic tool.
Publication Name: CMC Contrast, Denmark) & Henrik Winther (Dako, Denmark) Pan Stanford Publihing