Through the deal, the companies aim to bring new next-generation sequencing-based oncology diagnostic kits to the Chinese market.
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.
Vivek Murthy is no longer the surgeon general of the US, the Associated Press reports.
People around the globe took to the streets to support science — some with signs.
Parents who learn of their increased genetic risk of disease also contend with telling their children about theirs, the New York Times writes.
In PLOS this week: loci linked to body mass index measurements, long non-coding RNA expression and urothelial carcinoma prognosis, and more.