On June 30, 2014, the State Food and Drug Administration approved the BGISEQ-1000 gene sequencer, BGISEQ-100 gene sequencer and fetal chromosome aneuploidy (T21, T18, T13) detection kit (joint Registration of medical device registration for probe anchored ligation sequencing method), fetal chromosomal aneuploidy (T21, T18, T13) detection kit (semiconductor sequencing method). This is the second-generation gene sequencing diagnostic product approved and registered for the first time by the State Food and Drug Administration.
This batch of products can perform gene sequencing of episomal gene fragments in the peripheral blood plasma of high-risk pregnant women over 12 weeks of gestation to detect fetal chromosomal aneuploidy 21-trisomy syndrome, 18-trisomy syndrome and 13- Trisomy syndrome performs non-invasive prenatal examination and auxiliary diagnosis.
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