Biomarkers for pharmacogenetic and pharmacogenomic studies: Locking down analytical performance

The use of in vitro tests to detect and measure biomarkers provides promising avenues for development of new and better drugs, and will be central to the realization of personalized medicine. The importance of proper biomarker test assessment cannot be overemphasized. Whether the test is being used as part of drug development or ultimately used as a companion diagnostic, if the test result is to be meaningful, the test analytical performance must be well characterized. This article will outline important analytical validation issues to consider when developing and assessing an in vitro diagnostic test system for use in pharmacogenetic and pharmacogenomic studies.

Section editor:Janet Woodcock – Food and Drug Administration, Rockville, MD, USA