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Regulating molecular diagnostic assays: developing a new regulatory structure for a new technology.

机译:调节分子诊断分析:为新技术开发新的调节结构。

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摘要

Molecular diagnostics are playing an increasingly important part in the practice of medicine. However, molecular diagnostics have not yet made the clinical impact that many had predicted. Multiple factors affect the uptake and utilization of molecular diagnostics, including government regulation. Current regulatory systems were not developed to optimize regulation of molecular diagnostics. This article recommends areas that should be carefully evaluated and appropriately revised, including risk assessment, review criteria and facilitating product improvements. The adoption of molecular diagnostics will be advanced as regulatory criteria become more predictable and their application becomes more consistent between products and over time.
机译:分子诊断在医学实践中起着越来越重要的作用。但是,分子诊断尚未产生许多人所预料的临床影响。多种因素影响分子诊断的使用和利用,包括政府法规。当前的调节系统尚未开发成优化分子诊断的调节。本文建议应仔细评估和适当修订的领域,包括风险评估,审查标准和促进产品改进。随着监管标准变得更加可预测,并且随着时间的推移,它们在产品之间的应用也将变得更加一致,因此分子诊断的采用将得到提高。

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