Release date: 2016-08-25

With the deepening of the understanding of gene sequencing and precision medicine, from the "13th Five-Year Plan" to the deployment of relevant departments' policies, in recent years, China has accelerated the pace of promoting the development of precision medicine. Xinhua News Agency reporters take stock of this.

In March 2014, the Health and Medical Administration of the National Health and Family Planning Commission issued a notice to carry out high-throughput gene sequencing pilots. The pilot projects include prenatal screening and prenatal diagnosis, genetic diagnosis, tumor diagnosis and treatment, and preimplantation. Embryonic genetic diagnosis, etc.

In June 2014, the State Food and Drug Administration approved the BGISEQ-1000 gene sequencer, BGISEQ-100 gene sequencer and fetal chromosome aneuploidy (T21, T18, T13) detection kits (joint probes). Anchored connection sequencing method, fetal chromosome aneuploidy (T21, T18, T13) detection kit (semiconductor sequencing method) medical device registration. This is the second generation of genetic sequencing diagnostic products approved by the State Food and Drug Administration for the first time.

In January 2015, the National Health and Welfare Commission for Maternal and Child Health Services issued the “Notice on the Prenatal Diagnostic Institutions for High-throughput Gene Sequencing Prenatal Screening and Diagnostic Clinical Application Pilots”, and approved 109 hospitals for high-throughput sequencing non-invasive The pre-natal screening clinical trials are mainly based on medical institutions.

In January 2015, the National Health and Welfare Commission for Maternal and Child Health Services issued the “Notice on the pilot application of high-throughput gene sequencing for preimplantation embryo genetic diagnosis in assisted reproductive institutions”, and approved 13 medical institutions to carry out Qualcomm. Genetic sequencing of pre-implantation genetic diagnosis clinical trials.

In March 2015, the Medical and Health Management Department of the National Health and Family Planning Commission issued the “Notice on the Pilot Work of Clinical Application of High-throughput Gene Sequencing Technology for Tumor Diagnosis and Therapy”, and announced the first batch of high-throughput tumor diagnosis and treatment programs. List of clinical pilot units for gene sequencing technology.

In April 2015, the National Health and Family Planning Commission issued the “Notice on Conducting Inter-laboratory Quality Evaluation of High-throughput Sequencing Detection (Multi-Gene Detection) for Tumor Diagnosis and Treatment”, indicating that the inter-room quality evaluation of the project will be carried out. Pre-research, investigate the relevant laboratories across the country.

In May 2015, the State Council issued the “Decision on Cancellation of Non-Administrative License Approval Items” to cancel the approval of the third category of medical technology clinical application, including the third type of medical technology such as hematopoietic stem cell transplantation, gene chip diagnosis, and immune cell therapy. application.

In June 2015, the “Notice of the National Development and Reform Commission on Implementing Major Engineering Packages for Emerging Industries” was released, and the Genetic Testing Technology Application Demonstration Center was included in the “New Health Technology Huimin Project”, one of the six key engineering fields.

In July 2015, the Health and Medical Management Division of the Health and Family Planning Commission issued the "Technical Guidelines for Gene Detection of Drug Metabolizing Enzymes and Drug Targets (Trial)" and "Technical Guidelines for Individualized Treatment of Tumors (Trial)" to further improve clinical laboratories. Carry out gene detection technology for drug-metabolizing enzymes and drug targets, and standardization level of gene detection technology for individualized drugs.

In August 2015, the National Natural Science Foundation of China announced the results of the 2015 application project review. The Third Military Medical University’s analysis of the massive parallel sequencing data of 10,000 cases of deafness in China and the identification and pathogenesis of three new deafness genes The project, Peking University's "Human genome genomic mutation identification and quantitative bioinformatics new method development and mutation law mining" projects have been supported.

In August 2015, the General Office of the People's Government of Hunan Province issued a notice on “Several Policies for Promoting the Application of Genetic Testing Technology in Hunan Province (Trial)”, aiming to promote the development and popularization of genetic testing technology in the province, and promote the prevention and control of genetic testing technology in major diseases. The application on the promotion of health benefits.

In September 2015, the Guizhou Provincial Government issued the “Supporting Policy Measures for the Application of Genetic Testing Technology (Trial)”, proposing to explore the establishment of financial subsidies, medical insurance reimbursement and personal payment for the gene testing and payment mechanism, and accelerate the promotion of therapeutic drug gene testing. The detection of rare disease genes is included in the scope of medical insurance payment as required.

In January 2016, the Chinese Academy of Sciences announced the launch of the “China Population Accurate Medical Research Program”, which will complete the collection of DNA samples and phenotypic data of 4,000 volunteers within 4 years, and conduct in-depth precision medical research on 2,000 of them.

In March 2016, “genomics” was included in the “13th Five-Year Plan” draft plan: “Strategic Emerging Industry Development Action” proposed “accelerating the large-scale application of biotechnology such as genomics”.

In April 2016, the General Office of the National Development and Reform Commission issued a reply letter, and approved the construction of 27 genetic testing technology application demonstration centers nationwide to accelerate the standardization and leapfrog development of China's genetic industry from the national strategic level, aiming at vigorously developing genetic testing. Technology to improve the prevention and treatment of major diseases such as birth defects, hereditary diseases, tumors, cardiovascular and cerebrovascular diseases, infectious diseases, etc., and comprehensively improve the quality of the population.

In June 2016, the National Health and Technology Commission's Center for Medical and Health Science and Technology Development published a website on the website of the National Key Research and Development Program “Precision Medical Research” 2016. “Clinical Single Cell Cytochemistry Technology Development” 61 cases including the disease cohort study were selected.

Source: China Securities Network

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