Microarray Technology: Unresolved Issues and Future Challenges from a Regulatory Perspective

Abstract

Despite their growing popularity in the research community, DNA microarray- based gene expression assays have not yet been approved or licensed by the U.S. Food and Drug Administration for clinical or regulatory decision-making. While recent publi- cations demonstrated the technical reliability of microarray technology, there are several challenges that still need to be addressed so that microarray-based gene expression data can be accepted for routine use in clinical and regulatory environments. First, appropri- ate quality-control metrics and thresholds are needed for objectively assessing the quality of microarray data from individual laboratories. Secondly, consensus on the analysis of microarray data is needed. Thirdly, adequate evaluation and validation of microarray re- sults is needed so that non-reproducible chance correlations can be avoided in handling high-dimensional microarray data.