实验室自建项目在现代医学发展中面临的机遇和挑战

Laboratory developed tests in the development of modern medicine： opportunities and challenges

转化医学和个体化医学正在成为现代医学发展的新动力。技术为基础发展壮大起来的实验室自建项目（LDTs）是转化医学和个体化医学实施和发展过程中迫切需要和十分重要的一环。现代的LDTs多指采用细胞遗传学或分子生物学试验方法，分析核酸、线粒体、蛋白组和代谢组生物标志物、细胞表面分子等的体外诊断试验，常用于检测遗传性或获得性疾病相关的基因型、突变型或表型；病变细胞的分类等。目前对新一代LDTs的规范和监管正在探讨中。临床实验室应逐步建立完善LDTs的检测平台、质量控制体系和管理标准，搭建起科学研究与临床应用之间转化沟通的桥梁。

Translational medicine and personalized medicine are becoming the new power in modern medical development. Laboratory Developed Tests （ LDTs ） based on molecular biology and bioinformatics technology play a vital role in the development process of translational medicine and personalized medicine. Nowadays, LDTs consist of a broad range of in vitro diagnositc tests performed to analyze nucleic acid, chromosomes,proteins, certain metabolites and cell surface molecules using immunological technique, cytogenetic or molecular methods or a combination-of these methods. These LDTs are used to detect heritable or acquired disease-related genotypes, mutations, or phenotypes, and also used to classify the pathological changes of cells for clinical purposes. New generation LDTs, present some unique regulatory questions still remain to be discussed. Clinicians should capture the opportunity to establish and continuously improve the detection platforms of LDTs, the quality control system and management standards. On this basis, transformation bridges between scientific research and clinical application will be truly built.