疾病诊断新标志物挖掘转化中产业化链思考

How to build networks on the way of translational medicine about new biomarkers for diagnosis

利用生物标志物精准的检测开展"早期发现、早期诊断及有效个体化治疗"是重大疾病防控的关键和重要途径之一。基因组学、蛋白质组学等经过一二十年的发展,已经发现了数百个潜在的疾病标志物,但目前可用于临床的标志物尚屈指可数。标志物挖掘转化中的大漏斗现象凸显存在,已成为转化医学平台中的瓶颈,也是生物产业领域期待突破的关口。本文从标志物研究转化现状、产业化技术平台、转化模式、体外诊断试剂注册法规等方面对疾病诊断用新标志物挖掘转化中的产业化链建设进行了思考。

Accurate detection with biomarkers special for diseases＇ early stage or individual therapy is one of the key ways to prevent and control the major and critical diseases. Hundreds of potential biomarkers have been discovered by genomics and proteomics during the past twenty years. Regretfully, only few have been validated and translated forward to clinical use. The great gap is observably existed between academia and industry, and become the bottleneck on the way of successful translation. In this issue, the status and effective network models of new diagnostic biomarkers on the way of translational research are discussed constructively.