at home and abroad in 2016 on the gene industry has a lot of relevant policies, an industry vigorous development requires not only the continuous infusion of capital, the policy needs more powerful baton to guide the healthy development of the industry, regulation.
16 years, Hubei, Fujian NIPT pricing, respectively 1460/ times, 1400/ times; 16 years, has been in the “frozen” state of clinical laboratory project (LDT) the emergence of the “warmer” possible; 16 years, the clinical application of consensus Chinese first two generation sequencing technology introduction, CFDA released “NGS detection reagent quality technical evaluation of general technology of” guiding principles, improve the access threshold, the reasonable application of NGS gene detection and guidance, norms.
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Domestic articles
[1] CFDA collection of 4 types of medical equipment manufacturing enterprises information:
From January 8th to 22, the State Food and drug administration center medical review issued a solicitation of 4 kinds of medical information production enterprises. Are: 1 genotyping of hepatitis C virus detection reagent kit; related detection of 2 blood type and automatic blood analyzer; 3.Her-2 gene detection kit (fluorescent in situ hybridization); 4 Mycobacterium tuberculosis drug resistance gene mutation detection reagent.
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The technical review of these 4 types of medical guidelines are being prepared, the day after will be introduced. These 4 types of medical 3 belongs to diagnostic reagents, 1 belong to the testing equipment. Is a good thing for the major diagnostic reagents field enterprises.
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