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Medical applications of microarray technologies: a regulatory science perspective

Nature Genetics volume 32, pages 474–479 (2002)Cite this article

Abstract

The potential medical applications of microarrays have generated much excitement, and some skepticism, within the biomedical community. Some researchers have suggested that within the decade microarrays will be routinely used in the selection, assessment, and quality control of the best drugs for pharmaceutical development, as well as for disease diagnosis and for monitoring desired and adverse outcomes of therapeutic interventions. Realizing this potential will be a challenge for the whole scientific community, as breakthroughs that show great promise at the bench often fail to meet the requirements of clinicians and regulatory scientists. The development of a cooperative framework among regulators, product sponsors, and technology experts will be essential for realizing the revolutionary promise that microarrays hold for drug development, regulatory science, medical practice and public health.

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Author information

Authors and Affiliations

  1. Division of Therapeutic Products, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, FDA, Bethesda, 20892, Maryland, USA

    Emanuel F. Petricoin III

  2. Division of Clinical Laboratory Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Rockville, 20850, Maryland, USA

    Joseph L. Hackett

  3. Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, FDA, Rockville, 20857, Maryland, USA

    Lawrence J. Lesko

  4. Division of Cell and Gene Therapy, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, FDA, Bethesda, 20892, Maryland, USA

    Raj K. Puri

  5. Division of Clinical Laboratory Devices, Office of Device Evaluation, Center for Devices and Radiological Health, FDA, Rockville, 20850, Maryland, USA

    Steven I. Gutman

  6. Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA, Bethesda, 20892, Maryland, USA

    Konstantin Chumakov

  7. Office of the Director, Center for Drug Evaluation and Research, FDA, Rockville, 20852, Maryland, USA

    Janet Woodcock

  8. Office of the Director, Center for Devices and Radiological Health, FDA, Rockville, 20850, Maryland, USA

    David W. Feigal Jr.

  9. Office of the Director, Center for Biologics Evaluation and Research, FDA, Bethesda, 20892, Maryland, USA

    Kathryn C. Zoon

  10. Division of Applied Pharmacology Research, Office of Testing and Research, Center for Drug Evaluation and Research, FDA, Laurel, 20708, Maryland, USA

    Frank D. Sistare

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  1. Emanuel F. Petricoin III
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Correspondence to Emanuel F. Petricoin III or Frank D. Sistare.

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Petricoin, E., Hackett, J., Lesko, L. et al. Medical applications of microarray technologies: a regulatory science perspective. Nat Genet 32 (Suppl 4), 474–479 (2002). https://doi.org/10.1038/ng1029

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