| QA/QC issues to aid regulatory acceptance of microarray gene expression data. | |
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MedLine Citation:
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PMID: 17567852 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The U.S. Food and Drug Administration is responsible for (1) promoting and protecting public health by assuring the safety and effectiveness of medicines and medical devices and (2) advancing public health by helping to speed innovations that make medicines and foods safer, more effective, and more affordable. The genomics revolution has dramatically increased our knowledge of basic biology but this has not resulted in the expected acceleration of new medical product development. The Agency's Critical Path to New Medical Products stresses that new tools are needed to address this pipeline problem. Microarray technology is one of these promising tools although questions have risen about the reproducibility of measurements. The Microarray Quality Control (MAQC) Project was initiated by FDA scientists to address this issue. This large project, which evaluated reference RNA samples on seven microarray platforms, found good intralaboratory repeatability and interlaboratory reproducibility. In addition, there was high cross-platform consistency. All data are available free of cost and the reference RNA samples are available for proficiency testing. Thus, current microarray technology appears to provide both reliability and consistency for regulatory submissions. |
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Authors:
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James C Fuscoe; Weida Tong; Leming Shi |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Environmental and molecular mutagenesis Volume: 48 ISSN: 0893-6692 ISO Abbreviation: Environ. Mol. Mutagen. Publication Date: 2007 Jun |
Date Detail:
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Created Date: 2007-07-30 Completed Date: 2007-09-04 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8800109 Medline TA: Environ Mol Mutagen Country: United States |
Other Details:
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Languages: eng Pagination: 349-53 Citation Subset: IM |
Affiliation:
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Center 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 |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Gene Expression Profiling
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statistics & numerical data* Oligonucleotide Array Sequence Analysis / methods, standards* Quality Control Reproducibility of Results United States United States Food and Drug Administration |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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