How industry is approaching the search for new diagnostic markers and biomarkers
How industry is approaching the search for new diagnostic markers and biomarkers
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DOI：
10.1074/mcp.m400007-mcp200
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发表时间：
2004-04-01
影响因子：
7
通讯作者：
Langen, H
中科院分区：
文献类型：
--
作者：
Zolg, JW;Langen, H
在诊断和制药行业中，不断需要具有更高灵敏度和特异度的新的诊断标志物和生物标志物。在过去的5年里，只有几个新的诊断标记物被引入市场。蛋白质组学技术现在为识别新的候选标记提供了独特的机会。在将标记引入市场之前，必须完成三个连续的开发阶段：发现阶段，在此阶段应用各种蛋白质组学技术来确定标记候选；原型开发阶段，在此阶段，免疫学分析被建立并在定义的样本集合中进行验证；最后是产品开发阶段，其分析格式适用于自动化平台。一个潜在的候选市场在进入市场之前的每个发展阶段都必须通过相当大的障碍。成本正在从一个阶段增加到另一个阶段，在工业中，在蛋白质组学发现项目开始之前，必须回答一些关于医疗需求和潜在投资回报的问题。在这篇综述中，我们将涵盖所有三个发展阶段的方面，包括蛋白质分离的发现工具以及用于鉴定蛋白质的现代质谱学原理的概述。
In the diagnostic and the pharmaceutical industry there is a constant need for new diagnostic markers and biomarkers with improved sensitivity and specificity. During the last 5 years, only a few novel diagnostic markers have been introduced into the market. Proteomics technologies are now offering unique chances to identify new candidate markers. Before a marker can be introduced into the market, three successive developmental phases have to be completed: the discovery phase, in which a variety of proteomics technologies are applied to identify marker candidates; the prototype developmental phase, in which immunological assays are established and validated in defined sample collectives; and finally the product development phase, with assay formats suitable for automated platforms. The hurdles that a potential candidate marker has to pass in each developmental phase before reaching the market are considerable. The costs are increasing from phase to phase, and in industry a number of questions concerning the medical need and the potential return on investment have to be answered before a proteomics discovery project is started. In this review, we will cover aspects of all three developmental phases including the repertoire of discovery tools for protein separation as well as giving an outline of modern principles of mass spectrometry for the identification of proteins.