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Medical applications of microarray technologies: a regulatory science perspective.
Emanuel F Petricoin1, Joseph L Hackett, Lawrence J Lesko
1Division of Therapeutic Products, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, FDA, Bethesda, Maryland 20892, USA. petricoin@cber.fda.gov
Nature Genetics
|November 28, 2002
Summary
Microarray technology offers significant potential for drug development, disease diagnosis, and monitoring therapeutic outcomes. Realizing this promise requires collaboration between researchers, clinicians, and regulators to overcome implementation challenges.
Area of Science:
- Biomedical research
- Medical technology
- Pharmaceutical development
Background:
- Microarrays have generated excitement and skepticism regarding their medical applications.
- Potential uses include drug selection, disease diagnosis, and monitoring treatment outcomes.
Purpose of the Study:
- To explore the potential medical applications of microarrays.
- To identify challenges in translating microarray technology from research to clinical practice.
Main Methods:
- This abstract discusses the potential applications and challenges of microarray technology.
- It emphasizes the need for a cooperative framework.
Main Results:
- Microarrays show promise for routine use in pharmaceutical development and clinical practice within a decade.
- Breakthroughs often face hurdles in meeting clinical and regulatory requirements.
Conclusions:
- Realizing the full potential of microarrays requires a collaborative framework involving regulators, product sponsors, and technology experts.
- This collaboration is essential for advancements in drug development, regulatory science, medical practice, and public health.