分子诊断能够通过一系列的分子生物学方法,对机体及外来病原体的核酸物质或其相应的表达水平进行检测,是目前提供诊断依据或参考的重要手段之一,也是体外诊断的重要组成部分。分子诊断行业虽对技术能力要求较高,但仍是发展最为迅速的体外诊断子行业。分子诊断行业的发展经历了四个阶段,从最初的DNA分子杂交技术到PCR技术,再到生物芯片技术和高通量测序技术。在我国,分子诊断技术虽起步较晚,但无论是分子诊断市场还是分子诊断技术都发展迅速。诸如血源核酸筛查、人类乳头瘤病毒(HPV)分子筛查、新型冠状病毒核酸检测等新兴分子检测领域发展迅猛;高通量测序技术等新技术的发展成熟和应用,带来肿瘤精准诊断、生育健康筛查等检测市场的快速增长。分子诊断作为目前不可或缺的检测手段,为人类健康带来持续的保障,也将助推我国分子诊断产业持续蓬勃发展。
<<Molecular diagnostics is a collection of molecular biology techniques used to detect the genome or gene expression of human and pathogens. And the Molecular diagnostic market has emerged as one of the important and fastest growing segment in the in-vitro diagnostic industry. There are four stages in the development of molecular diagnostics:molecular hybridization,polymerase chain reaction(PCR),biochip technology and high-throughput sequencing(also known as next-generation sequencing,NGS). In China,molecular diagnostic techniques were slow-growing in the early period. But the Molecular diagnostic market size has been expanded at a high growth rate in these years,and the molecular diagnostic technology has also been developed so quickly. The rapid growth of the new molecular detection area of nucleic acid,such as blood screening,human papillomavirus(HPV)screening and 2019-nCoV detection,etc. With the development and application of high-throughput sequencing,the detection market of tumor accurate diagnosis and reproductive health screening are growing rapidly. Overall,Molecular diagnostics is very important to human health,and the Molecular diagnostic market will continue to flourish.
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