Presenter - Janet A. Warrington, Ph.D.
Senior Director, Clinical Genomics Research & Development
Affymetrix, Inc.

Standards drive acceptance and success of new technologies in all clinical application areas. Genomics information generated by microarrays is rapidly moving towards clinical applications. The value and necessity of developing standards for microarrays was highlighted by a NIST meeting at Stanford University, Spring 2003. While significant progress has been made in standardization of some commercially produced microarrays by reducing sources of variability in their manufacture, there remain many opportunities for developing standards for sample acquisition, stabilization, processing, assay and analysis as well as external RNA reference controls. One of the positive outcomes of the NISTmeeting was the formation of a collective effort to develop external RNA reference control standards. In addition to this effort, other working groups have formed jointly between industry, academia and national institutes to develop standardized protocols for blood handling and stabilization for expression analysis, guidelines for low level expression analysis and protocols for paraffin embedded sample expression analysis. Assay reproducibility, robustness, sensitivity and specificity are key areas of investigation in each of these efforts. The working groups are striving to develop practical, informative, robust best practices protocols and reagents while building consensus in the clinical research community. These standardized protocols and best practices promise to accelerate the benefit microarrays can bring to clinical care.