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

James C Fuscoe1, Weida Tong, Leming Shi

  • 1Center for Functional Genomics, Division of Systems Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, Arkansas 72079, USA. james.fuscoe@fda.hhs.gov

Environmental and Molecular Mutagenesis
|June 15, 2007
PubMed
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Microarray technology shows good reliability and consistency for medical product development. The FDA

Area of Science:

  • Genomics and Bioinformatics
  • Regulatory Science
  • Biotechnology

Background:

  • The genomics revolution has not accelerated new medical product development as expected.
  • New tools are needed to improve the medical product development pipeline.
  • Microarray technology is a promising tool, but its measurement reproducibility is questioned.

Purpose of the Study:

  • To address concerns about the reproducibility of microarray technology measurements.
  • To evaluate the reliability and consistency of microarray technology for regulatory submissions.

Main Methods:

  • The Microarray Quality Control (MAQC) Project involved FDA scientists.
  • Reference RNA samples were evaluated across seven different microarray platforms.
  • Intralaboratory repeatability and interlaboratory reproducibility were assessed.

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Main Results:

  • Microarray technology demonstrated good intralaboratory repeatability.
  • High interlaboratory reproducibility was observed across multiple platforms.
  • Excellent cross-platform consistency was found, supporting its use.

Conclusions:

  • Current microarray technology provides reliable and consistent measurements.
  • Microarray technology is suitable for use in regulatory submissions for new medical products.
  • The MAQC Project data and reference RNA samples are publicly available.