Genetic Testing, also known as DNA Genetic testing, mainly involve Hospitals, Clinical Laboratory Centers, Instrument and Reagent, distributors, technical platforms and etc. in China, the related Supervision Departments for Genetic Testing are various and complex.
The first one is "National Development and Reform Commission" (NDRC)，NDRC constitutes Genetic Testing Industry development plan from Macro aspect. In June 2015, NDRC released "Notice of the national development and reform commission on the implementation of major projects in emerging industries", mentioned to intensely develop Genetic Testing innovative medical technologies, and establish 30 Genetic Testing Technology Application Demonstration Centers in 3 years. Local NDRC participates the pricing for Genetic Testing in local hospitals.
The second one is "National Health and Family Planning Commission" (NHFP). NHFP is in charge of reviewing and normalizing the Genetic Testing Organization's qualifications, three branches as Medical Affairs and Healthcare Reform Bureau, Maternity and Child Care Department and Clinical Laboratory Center are focusing on related issues from different perspectives.
The third one is "China Food and Drug Administration" (CFDA). CFDA supervises the instruments, reagents and analysis software for Genetic Testing from Safety and Effectiveness and issue the CFDA Certificates, such as Testing Kits, Gene Chips of EGFR, KRAS, BRAF, C-KIT, CYP2C9, CYP2C19. From High Throughput Sequencing perspective, CFDA have approved NIPT Gene Sequencing Analyzers and Reagents, but for Tumor Diagnosis, CFDA didn't approve any instrument or reagent till now.
From application area perspective, in China High Throughput Sequencing are only used for Inherited disease, NIPT, PGS/PGD and Tumor diagnosis and therapy in China. The Next Generation Gene Sequencing has bright future for Cardiovascular, Infectious diseases, Intestinal Microflora and Metagenome.
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