Biomarkers for pharmacogenetic and pharmacogenomic studies: special issues in analytical performance

The use of in vitro tests to detect and measure biomarkers will be central to the realization of personalized medicine. The importance of proper biomarker test development processes cannot be overemphasized; whether the test is being used as part of drug development or ultimately for use as a companion diagnostic, if the test result is to be meaningful, the test analytical performance must be well characterized and reliable. This article will outline important design issues and special analytical validation issues to consider when developing and assessing an in vitro diagnostic test system for use in pharmacogenetic and pharmacogenomic studies. Of particular importance is understanding that good analytical performance is a result of a well-coordinated analytical system specifically designed to provide quality results.

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