QA/QC issues to aid regulatory acceptance of microarray gene expression data.

The U.S. Food and Drug Administration is responsible for (1) promoting and protecting public health by assuring the safety and effectiveness of medicines and medical devices and (2) advancing public health by helping to speed innovations that make medicines and foods safer, more effective, and more affordable. The genomics revolution has dramatically increased our knowledge of basic biology but this has not resulted in the expected acceleration of new medical product development. The Agency's Critical Path to New Medical Products stresses that new tools are needed to address this pipeline problem. Microarray technology is one of these promising tools although questions have risen about the reproducibility of measurements. The Microarray Quality Control (MAQC) Project was initiated by FDA scientists to address this issue. This large project, which evaluated reference RNA samples on seven microarray platforms, found good intralaboratory repeatability and interlaboratory reproducibility. In addition, there was high cross-platform consistency. All data are available free of cost and the reference RNA samples are available for proficiency testing. Thus, current microarray technology appears to provide both reliability and consistency for regulatory submissions.