摘要
随着精准医疗和抗肿瘤药物的飞速发展,靶向治疗和免疫治疗的应用越来越广泛,通过伴随诊断试剂检测合适的生物标志物,筛选出对药物疗效更加敏感的患者,可以使患者在临床诊疗得到更加精准的治疗。目前应用高通量测序方法进行伴随诊断试剂检测的产品日益增多,本文对于国内外基于NGS方法的伴随诊断产品进行分析探讨,为相关产品的上市评价提供参考。
With the rapid development of precision medicine and antitumor drugs,the application of targeted therapy and immunotherapy is becoming more and more extensive.Monitoring suitable biomarkers through companion diagnostic reagents and screening patients who are more sensitive to drug efficacy can enable patients to clinical diagnosis and treatment get more precise treatment.At present,the number of products using high⁃throughput sequencing methods for companion diagnostic reagent detection is increasing,this review analyzes and discusses the companion diagnostic products based on NGS method,and provides a reference for the market evaluation of related products.
作者
李冉
方丽
徐超
LI Ran;FANG Li;XU Chao(Center for Medical Device Evaluation,National Medical Products Administration,Beijing,China,100081)
出处
《分子诊断与治疗杂志》
2023年第3期541-544,共4页
Journal of Molecular Diagnostics and Therapy
关键词
精准医疗
高通量测序
伴随诊断试剂
Precision medicine
High⁃throughput sequencing
Companion diagnostic reagents