NEW YORK (GenomeWeb) – BGI today announced that China's National Health and Family Planning Commission has approved it to conduct high-throughput clinical genetic sequencing services for cancer.
The commission approved BGI's clinical laboratories in Shenzhen and Tianjin for the services last month, BGI said. The approval is the latest by Chinese regulators for BGI following a decision a year ago by Chinese authorities that genetic testing needed to be regulated, in particular sequencing-based prenatal genetic testing. Following the announcement, BGI suspended the clinical application of its non-invasive fetal trisomy test, called NIFTY, in China.
Shortly afterward, though, China's Food and Drug Administration approved BGI's registrations of its BGISeq-1000 and BGISeq-100 sequencers, as well as its diagnostic kits, for fetal chromosomal aneuploidy. CFDA also simultaneously cleared the NIFTY test.
This past January the company was approved to perform high-throughput clinical genetic sequencing on genetic disorder diagnosis, prenatal screening and diagnosis, and preimplantation genetic diagnosis in China, BGI noted.