National Cancer Institute-Food and Drug Administration Interagency Oncology Task Force on Molecular Diagnostics, National Institutes of Health, Bethesda, MD 20892, USA.
Clin Chem. 2010 Feb;56(2):237-43. doi: 10.1373/clinchem.2009.136416. Epub 2009 Dec 10.
Clinical proteomics has the potential to enable the early detection of cancer through the development of multiplex assays that can inform clinical decisions. However, there has been some uncertainty among translational researchers and developers as to the specific analytical measurement criteria needed to validate protein-based multiplex assays. To begin to address the causes of this uncertainty, a day-long workshop titled "Interagency Oncology Task Force Molecular Diagnostics Workshop" was held in which members of the proteomics and regulatory communities discussed many of the analytical evaluation issues that the field should address in development of protein-based multiplex assays for clinical use. This meeting report explores the issues raised at the workshop and details the recommendations that came out of the day's discussions, such as a workshop summary discussing the analytical evaluation issues that specific proteomic technologies should address when seeking US Food and Drug Administration approval.
临床蛋白质组学有可能通过开发能够为临床决策提供信息的多重分析来实现癌症的早期检测。然而，在转化研究人员和开发者中，对于验证基于蛋白质的多重分析所需的具体分析测量标准存在一些不确定性。为了解决这种不确定性的原因，举行了为期一天的题为“机构间肿瘤学工作组分子诊断研讨会”的研讨会，蛋白质组学和监管界的成员在会上讨论了该领域在开发用于临床用途的基于蛋白质的多重分析时应解决的许多分析评估问题。本会议报告探讨了研讨会上提出的问题，并详细介绍了当天讨论得出的建议，例如讨论特定蛋白质组学技术在寻求美国食品和药物管理局批准时应解决的分析评估问题的研讨会总结。
