Microarray Technology: Unresolved Issues and Future Challenges from a Regulatory Perspective
作者： Leming Shi , Federico M. Goodsaid , Felix W. Frueh , Weida Tong
关键词: Data science 、 Research community 、 Food and drug administration 、 Gene chip analysis 、 Computer science 、 Microarray 、 DNA microarray 、 Microarray analysis techniques
摘要: Despite their growing popularity in the research community, DNA microarray-based gene expression assays have not yet been approved or licensed by U.S. Food and Drug Administration for clinical regulatory decision-making. While recent publications demonstrated technical reliability of microarray technology, there are several challenges that still need to be addressed so data can accepted routine use environments. First, appropriate quality-control metrics thresholds needed objectively assessing quality from individual laboratories. Secondly, consensus on analysis is needed. Thirdly, adequate evaluation validation results non-reproducible chance correlations avoided handling high-dimensional data.
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