Challenges in DNA Microarray Studies from the Regulatory Perspective

Abstract

Genomic classifiers using DNA microarrays are becoming powerful tools in the medical community with the potential to revolutionize the diagnosis and treatment of disease. However, despite the tremendous interest in using these classifiers in diagnosis and the management of disease, few genomic classifiers have made it into clinical practice. Some of the major challenges for the development and validation of genomic classifiers will be discussed in this article together with some of their difficulties.

Key Words:

• Classifiers
• Microarrays
• Normalization
• Prediction accuracy
• Reproducibility

ACKNOWLEDGMENTS

The author thanks Dr. Lilly Q. Yue for her invitation of the article and the referees for their helpful comments. The author also thanks Dr. Estelle Russek-Cohen and Dr. Gene Pennello for their helpful comments on this manuscript.

No official support or endorsement by the Food and Drug Administration of this paper is intended or should be inferred.