下一代测序伴随诊断与抗肿瘤药物同步开发研究进展

Research progress in the co-development of next-generation sequencing companion diagnosis and antitumor drugs

目的:介绍美国下一代测序伴随诊断与抗肿瘤药物研发的历程以及监管政策,为我国下一代测序伴随诊断与抗肿瘤药物研发提供参考。方法:通过文献研究、案例分析、对比分析方法,从美国下一代测序伴随诊断法规指南及美国FDA已批准产品,对我国下一代测序伴随诊断监管及企业研发面临的挑战进行阐述。结果与结论:下一代测序伴随诊断与抗肿瘤药物的同步开发能探索并明确药物作用机制,精准识别患者,提高抗肿瘤药物研发成功率。随着精准医疗时代的到来,下一代测序技术的快速发展以及以临床价值为导向的抗肿瘤药物的研发政策出台,我国下一代测序伴随诊断与抗肿瘤药物同步开发越来越多,需要提出对应的监管政策及研发指南,推进下一代测序伴随诊断的发展。

Objective:To introduce the history and regulatory policies of next-generation sequencing companion diagnosis and antitumor drug research and development in the United States in order to provide reference for practitioners in China.Methods:Using literature research,case analysis,and comparative analysis,the challenges faced by China's next-generation sequencing companion diagnostics supervision and enterprise research and development were elaborated from the regulatory guidelines for next-generation sequencing companion diagnostics in the United States and the products approved by the US Food and Drug Administration.Results and conclusion:Co-development of next-generation sequencing companion diagnosis and antitumor drugs can help explore and clarify the mechanism of drug action,accurately identify patients,and increase the success rate of antitumor drug development.With the advent of the era of precision medicine,the rapid development of next-generation sequencing technology and the policy of clinical value-oriented anti-tumor drug research and development,China's next-generation sequencing companion diagnosis and anti-tumor drug development are increasingly synchronous.It is necessary to propose corresponding regulatory policies and research and development guidelines to promote the development of next-generation sequencing companion diagnosis.