- BGI Genomics Announces Pricing of Initial Public Offering
- BGI Launches the Latest Desktop Sequencer BGISEQ-50
- International Science Community Welcomes China National GeneBank Opening
- BGI and Clearbridge BioMedics Partner to Develop China CTC Liquid Biopsy Market towards Precision Medicine
- The international Sc2.0 Project is on track to build the world’s first synthetic yeast genome
- Avian-specific conserved genomic elements play important regulatory roles in the macroevolution of avian-specific features
- The Evolution of Chronic Lymphocytic Leukemia Revealed
- BGI involved in publication of the first seahorse genome in Nature
- Leading Health Organizations in Canada and China Teaming up to Accelerate Precision Medicine
- World’s largest genomic organisation to collaborate with leading Queensland researchers
- Ranomics Partners with BGI to Classify Variants of Unknown Significance
- BGI and UW collaborate on precision medicine development
- Chinese innovation : BGI’s code for success
- First Round Conference Announcement: The 13th Annual Meeting of the International Conference on Genomics
- Prof. Huanming Yang to Receive Membership from Royal Danish Academy of Sciences and Letters
- UW, Chinese genomics group forge new partnership to advance biomedical research
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On July 2, 2014, China Food and Drug Administration (CFDA) announced the approval of next generation sequencing diagnostic products.
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 diagnosis，encourages 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.
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