Strategy for gene expression-based biomarker discovery.

INTRODUCTION A validated and effective gene expression-based, biomarker discovery process can be an incredibly valuable and often necessary tool in drug discovery, development, and diagnostic research. However, to successfully implement a biomarker signature discovery program and mine the most value out of such a program, one needs to have access to a broad range of expertise, both biological and statistical, as well as sophisticated tools for performing the laboratory and data analysis processes that enable research and commercial applications. Access to these skills and the tools necessary to support biomarker or signature discovery efforts may come from internally funded and constructed resources or through exterior collaborations, or in the case of the Signature DiscoveryTM Program developed by Althea Technologies (San Diego, CA, USA) and Expression Analysis (Durham, NC, USA), outsourced to a sole-source development provider. Whichever direction best suits your development and validation needs, several critical steps should be closely adhered to, from both biological and statistical perspectives. Our goal here is to provide an overview and some insights that identify these critical paths along your discovery activities.