[9] China food and Drug Inspection Institute issued the “second generation sequencing detection reagent quality assessment of general technology guiding principle” announcement:
According to the guideline intended use of NGS kit including but not limited to the following: tumor related gene abnormalities, gene related genetic diseases, abnormal preimplantation chromosome aneuploidy, chromosomal aneuploidy and pathogenic microorganism detection and clinical application. This involves a kit for detection of NGS technology including targeted sequencing and non targeted sequencing: targeted sequencing refers to partial sequencing in the sample genome, such as target gene sequence and exon sequencing (Group); non targeted sequencing refers to the sequence of potential organisms in the sample genome. Enterprise principle does not recommend the use of whole genome sequencing for detection, if the enterprise application of whole genome sequencing technology, should be carried out to validate the applicability of the technology fully and submit a report. Samples are samples of the source (such as body fluids or tissues and excretion) or pathogenic microorganisms isolated cultures (such as blood culture, sputum culture, etc.) the detected object can be deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) or a mixture of the two.
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[10] the State Council issued the “13th Five-Year” National Science and technology innovation plan “:
In August 8th, the State Council officially issued the “13th Five-Year” National Science and technology innovation plan “(hereinafter referred to as the” plan “). “Planning” is referred to the “medicine” is a word of nearly 20 times, involving the accurate medical treatment, gene editing, immunotherapy, stem cells and other hot areas. At the same time, the “planning” pointed out the need to accelerate the transformation of China from a big country to pharmaceutical pharmaceutical powerhouse, focused on the deployment of common biological technology, new cutting-edge bio medicine, regenerative medicine and other leading technology innovation and application development, improve the level of the original biological technology.
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[11] Research Center of medical science and Technology Development Planning Commission issued the “precise medical research”:
In 2016 the first batch of key special project approval notice. According to the spirit of national development, 2014, 64, responsible for the management of research center of medical science and Technology Development Planning Commission of the national key research program focused on precise medical research has been completed according to the provisions of “special program project department work notice issued the first batch of a total of 56 bookmarks and task items, the number of projects 2016 annual funding work will be completed within two weeks.
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[12] the State Planning Commission: the basic standards of Medical Laboratory (implementation):
In October 18th, the national health and Family Planning Commission issued the “basic medical laboratory standard (Implementation)” document management, which stipulates: to carry out prenatal screening and prenatal diagnosis of experimental projects and technical personnel should have the corresponding qualifications of prenatal screening and diagnosis. To carry out the two generation sequencing project, at least 1 bioinformatics analysis of professional and technical personnel; to carry out genetic related gene detection project, at least 1 of medical genetics professionals.
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