China State FDA

Company highlights during the first half of 2017 include China approval for Novaprep for non-gynecological cancer testing, and a €3 million private financing round. 

Through the deal, the companies aim to bring new next-generation sequencing-based oncology diagnostic kits to the Chinese market.

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.

Pages

Using DNA to sketch crime victims might not be a great idea, the NYTimes says.

Science has its own problem with sexual harassment. What do we do with the research these abusers produce, Wired asks.

Senate Republicans led by Senator Rand Paul (R-KY) are trying to change how the government funds basic research, reports ScienceInsider.

In Science this week: combining genomics and ecology to better understand the effects of natural selection on evolution, and more.