BGI Diagnostics' NIFTY™ test becomes First NIPT based on Next Generation Sequencing Technology to be Approved by the China Food and Drug Administration (CFDA).
On June 30, 2014, the CFDA approved the registration of BGI's BGISEQ-1000 and BGISEQ-100 sequencers, and its prenatal genetic testing kits for NIFTY™ (Non-Invasive Fetal Trisomy test). This is the first genetic test based on next generation sequencing technology to be approved by the CFDA and makes the NIFTY™ test the only certified non-invasive prenatal test currently available in China.
The CFDA's approval for BGI's own-brand sequencers also highlights the fact that BGI has successfully transferred its technology from single to multiple platforms allowing the organisation to provide more varied product services in the field of genetic testing worldwide.
The NIFTY™ test is a highly accurate non-invasive maternal blood test, which detects the risk for certain fetal chromosomal (aneuploidy) disorders, such as Down syndrome, from as early as week 10 of pregnancy.