Accurate medical policy “when it is going on”: genetic sequencing technology continues to deepen

China's precision medicine policy is in the “time of progress”, and various departments are constantly strengthening and perfecting the system in the medical field. In recent years, with the deepening of the understanding of gene sequencing and precision medicine, from the "13th Five-Year Plan" to the deployment of relevant departments, China has accelerated the pace of promoting the development of precision medicine, and the media has taken stock.

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.

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