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CFDA Approved Next Generation Sequencing Diagnostic Products
Publish Date: 2014-07-02

On July 2, 2014, China Food and Drug Administration (CFDA) announced the approval of next generation sequencing diagnostic products.

Full text:

On June 30, 2014, CFDA approved the registrations of BGI’s sequencers BGISEQ-1000, BGISEQ-100 and its diagnostic kits for fetal chromosomal aneuploidy (Trisomy 21, Trisomy 18 and Trisomy 13) using the methods of semiconductor sequencing and joint probe anchor sequencing. These are the first next generation sequencing diagnostic products approved by CFDA.

These products can be applied for non-invasive prenatal testing and assisted diagnosis on fetal chromosomal aneuploidy diseases including Trisomy 21 (Down Syndrome), Trisomy 13 (Patau Syndrome), and Trisomy 18 (Edwards Syndrome), by sequencing cell-free fetal DNA in the maternal blood of high-risk pregnant women after 12 weeks of pregnancy. 

CFDA pays high attention to the industrial development of genetic sequencing diagnosisencourages innovation and improves services. With elaborate organization, cooperation and strict review system, CFDA has made good progress on the registration process while ensuring the safety and effectiveness of products. In the meantime, CFDA also initiated and completed the development of reference material for genetic sequencing diagnostic products.  

Next, CFDA will work closely with relevant departments, and strengthen the supervision on the quality of products on the market. CFDA will continue process the product registration of other innovative genetic sequencing diagnostic products, to promote the healthy and orderly development of industries, allowing faster and better public access to the innovative medical instruments.

Linkhttp://www.sda.gov.cn/WS01/CL0051/102239.html 

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