China State FDA | GenomeWeb

China State FDA

BGISEQ-50

The new BGISEQ-50, a smaller version of the BGISEQ-500, will have research and clinical applications, and BGI plans to register it with the CFDA, too.

China-based Burning Rock will develop cancer diagnostics for Chinese patients based on the Agilent SureSelect target enrichment system.

The diagnostic, a real-time PCR kit for breast cancer stratification, is being reviewed under a special process for the approval of innovative products.

Only about 5 to 6 percent of women in China, mostly in urban areas, currently obtain NIPT, but their number is expected to increase quickly in coming years.

The country recently implemented a pilot program issuing licenses to hospitals to run NGS tests for NIPT, PGS/PGD, cancer, and genetic disease.

Chinese regulators approved BGI's clinical laboratories in Shenzhen and Tianjin to conduct high-throughput clinical genetic testing services for cancer.

The NextSeq CN500 sequencer was developed in collaboration with Illumina to offer clinical non-invasive prenatal testing for the Chinese market.

The device is also CE marked for IVD use in Europe and approved in South Korea and Singapore for IVD use.

NEW YORK (GenomeWeb News) – Qiagen said on Monday that its QuantiFeron-TB Gold test has been approved for marketing in China.

NEW YORK (GenomeWeb News) – Life Technologies announced today regulatory approval in China for its Applied Biosystems 3500xL Dx Genetic Analyzer for clinical diagnostic use.
The company also said that 10 assays from its joint venture with Daan Gene have been launched.

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Pacific Biosciences is hosting a competition in which researchers are vying to win free sequencing for an organism with the most interesting genome.

An opinion piece appearing in Newsday likens familial DNA searches to stop-and-frisk policies.

The San people of Africa have drawn up a code of conduct for researchers, according to the Conversation.

In Nature this week: genotypes linked to hip osteoarthritis, and more.