Searching for "gene sequencing" on the Internet, you can see a number of medical institutions, physical examination centers, and even companies to provide medical check-up packages covering genetic testing for tumors, high blood pressure, diabetes, and other genetic tests, with prices ranging from hundreds of yuan to tens of thousands of yuan.
Just a drop of blood or a bit of saliva can predict the development of a variety of diseases, such as cancer or leukemia, the State Food and Drug Administration, the People's Republic of China *** and the National Health and Family Planning Commission of the State jointly issued a circular requiring that before the introduction of the relevant access standards, management norms, any medical institution shall not carry out clinical applications of gene sequencing; has been carried out, to stop immediately.
"Gene sequencing-related products and technologies have evolved from laboratory research to clinical use, to which the relevant departments of the State Council attach great importance." The State Food and Drug Administration (SFDA) and the National Health and Family Planning Commission of the People's Republic of China (NHFPC) are organizing experts in the relevant fields to argue the case after investigation and research. On the evening of February 17, 2014, the relevant person in charge of the State Food and Drug Administration admitted that the clinical application of gene sequencing is mostly found in medical institutions and physical examination centers for high-end physical examinations, but many of the gene sequencers and related diagnostic reagents and software used in them have not gone through the registration and approval of medical devices.
Du Bing, president of the Beijing Municipal Health Management Association, said on the evening of Feb. 17, 2014, that gene sequencing is not among the medical technology projects approved for access by the Beijing Municipal Health Administrative Department, and that there are no fees charged by the price department. State Food and Drug Administration on February 26, 2014 to respond to the gene sequencing technology "called off", said gene sequencing is a new technology in the field of genetic testing, although fast, low-cost, but also because it has not yet been through the regulatory authorities of the systematic evaluation of access, there are still risks to the safety and efficacy.
The State Food and Drug Administration also said that a number of domestic enterprises have been engaged in gene sequencing-related products, research, and applied to clinical, there is a trend to expand, but none of these products through the national review and approval of medical devices and registration, according to the law should be called to stop its clinical use. The two ministries jointly "called off" the clinical application of gene sequencing technology has triggered public concern.
Countries are more cautious about gene sequencing
PCR, biochips and other genetic testing technology has long been widely used in clinical practice, and its clinical use as a medical device, both at home and abroad have been approved. The State Food and Drug Administration Medical Device Registration Division of the relevant person in charge of the introduction, from 2008 to the present, China has successively approved a variety of products that can be used for genetic testing and supporting instrumentation, such as genetic testing reagents for hereditary deafness, human papillomavirus (HPV) DNA testing reagents, and clinical use of individualized medication related to oncology related to the detection of mutations associated with a variety of reagents.
However, as the research frontier of contemporary genetic testing technology, (second-generation) gene sequencing technology and products have been introduced since the introduction of the health and food and drug regulatory authorities in various countries have been concerned about their application and development in the field of clinical medicine, but have mostly taken a prudent attitude to promote them. In the United States, for example, until November 2013, the U.S. Food and Drug Administration (FDA) approved the first application of second-generation sequencing technology for "cystic fibrosis disease" diagnostic products, including related instruments and reagents. Similarly, in China, the person in charge said, the country has not approved the registration of medical devices based on (second-generation) gene sequencing technology.
Application for registration requires clinical trials
Gene sequencing diagnostic products include gene sequencers, diagnostic reagents and software. The State Food and Drug Administration (SFDA) introduced that gene sequencers and diagnostic software products used for clinical testing should apply for registration in accordance with the relevant procedures and requirements of the Measures for the Administration of Registration of Medical Devices; related in vitro diagnostic reagents can apply for registration in accordance with the Measures for the Administration of Registration of In Vitro Diagnostic Reagents (for Trial Implementation). The above products apply for approval and registration, but also need to be carried out first in the medical institutions of a certain number of samples of clinical trials, in order to verify the safety and effectiveness.
In order to encourage medical device research and innovation, the State Food and Drug Administration (SFDA) in February 2014 also issued the Special Approval Procedures for Innovative Medical Devices (for Trial Implementation). Yesterday, the State Food and Drug Administration said in response, if the application for registration of gene sequencing clinical diagnostic products in line with the definition of innovative medical devices, in accordance with the principle of "early intervention, specialists, scientific approval", in the premise of the standard is not reduced, the procedure is not reduced, priority review and approval, "support, The company's products and services are also available to the public as early as possible based on safety and efficacy evaluations.