China State FDA

MGI received medical device certification clearance for its MGISEQ-200 and MGISEQ-2000 instruments.

The Dublin-based company also aims to raise up to €5 million this year to support additions to its R&D and sales and marketing teams.

The company expects to be able to offer at least one test commercially by the end of this year or early next, with research now starting on two others.

The real-time PCR-based test is designed to identify EGFR mutations in circulating tumor DNA in plasma samples.

The kits cover the primary genetic targets currently used for assessing the compatibility of  hematopoietic cell donors with recipients.

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.

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Sometimes genetic tests give inconclusive results and provide little reassurance to patients, the Associated Press reports.

Vox wonders whether gene-editing crops will be viewed similarly as genetically modified organisms of if people will give them a try.

In Science this week: research regulation and reporting requirement reform, and more.

With H3Africa, Charles Rotimi has been working to bolster the representation of African participants and African researchers in genomics, Newsweek reports.