Analysis and Thinking on the Supervision of Companion Diagnostic Reagents
GONG Zhijun1, WU Shouxin2, JIANG Huihui3
1. National Medical Products Administration Institute of Executive Development, Beijing 100073, China; 2. Department of Research,
Shanghai Zhangjiang Medical Innovation Institute, Shanghai 200120, China; 3. Department of Scientific Research, Shanghai
Biotecan Medical Diagnostic Center Corporation, Shanghai 200120, China
Abstract：Precision medicine highly relies on in vitro diagnostic (IVD), which is also known as companion diagnostics (CDx)
when IVD is used to identify patients who are suitable for receiving specific drug treatment. Based on the important clinical value
and economic benefits of CDx reagent, the formulation of scientific and perfect regulatory policies for CDx is not only conducive
to the positive and balanced development of CDx industry, but also conducive to the popularization of precision medicine. This
paper compared the present situation of CDx reagent supervision in various countries, summarized the challenges faced by CDx
reagent regulation. Meanwhile, the trends and difficulties of CDx reagent supervision were analyzed, and the future development
trend of CDx industry was prospected, in order to provide reference for Chinese practitioners and regulators in the field of new drug
development and CDx.
弓志军1，吴守信2，姜慧慧3. 伴随诊断试剂监管分析与思考[J]. 中国医疗设备, 2023, 38(5): 173-179.
GONG Zhijun1, WU Shouxin2, JIANG Huihui3. Analysis and Thinking on the Supervision of Companion Diagnostic Reagents. China Medical Devices, 2023, 38(5): 173-179.
