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China FDA Approves BGI's NGS Products

NEW YORK (GenomeWeb) – The China Food and Drug Administration has approved next-generation sequencing-based products developed by BGI.

According to CFDA, it has approved BGISEQ-1000, BGISEQ-100, and diagnostic kits for fetal chromosomal aneuploidy that screen for trisomy 21, 18, and 13. The CFDA said the assays use semiconductor sequencing and joint probe anchor sequencing and will screen cell-free DNA in maternal plasma at 12 weeks or later gestation.

The products are the first NGS products approved by the CFDA. In March, BGI said it had suspended clinical testing of fetal trisomy following an announcement from Chinese officials that genetic testing should be regulated.