Bioinformatics advances for clinical biomarker development.

INTRODUCTION: Bioinformatics tools, techniques and resources are critical to biomarker discovery, assessment, validation, qualification, standardization and market acceptance into clinical practice. Huge scientific effort and economic investment over the past 20 years have resulted in thousands of new candidate biomarkers for diseases, yet relatively few biomarkers have entered clinical practice. Bioinformatics is central to all stages of biomarker development and implementation. AREAS COVERED: This review examines bioinformatics advances that bear on each stage of biomarker development and suggests bioinformatics strategies to assist biomarkers towards clinical practice. This paper focuses on the steps of clinical biomarker development with an emphasis on the review literature from 2000 to June 2011. The intent of this paper is to describe the present role of bioinformatics in biomarker development including the controversies associated with various developmental stages. EXPERT OPINION: The key message is that more effective biomarker development requires database input of higher quality, improved bioinformatics tools to identify more clearly the acceptable criteria for each development step, as well as more and better database linkages.