QA/QC issues to aid regulatory acceptance of microarray gene expression data
QA/QC issues to aid regulatory acceptance of microarray gene expression data
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DOI：
10.1002/em.20293
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发表时间：
2007-06-01
影响因子：
2.8
通讯作者：
Shi, Leming
中科院分区：
文献类型：
--
作者：
Fuscoe, James C.;Tong, Weida;Shi, Leming
美国食品和药物管理局负责（1）通过确保药品和医疗器械的安全性和有效性来促进和保护公共卫生;（2）通过帮助加快创新来促进公共卫生，使药品和食品更安全，更有效，更实惠。基因组学革命极大地增加了我们的基础生物学知识，但这并没有导致预期的新医疗产品开发的加速。FDA的《新医疗产品关键路径》强调，需要新的工具来解决这一管道问题。微阵列技术是这些有前途的工具之一，虽然问题已经上升的测量的再现性。微阵列质量控制（MAQC）项目是由FDA科学家发起的，旨在解决这一问题。这个大型项目在七个微阵列平台上评估了参考RNA样本，发现了良好的实验室内重复性和实验室间重复性。此外，跨平台的一致性也很高。所有数据都是免费提供的，参考RNA样品可用于能力验证。因此，目前的微阵列技术似乎为监管提交提供了可靠性和一致性。
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.