China State FDA

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

Since purchasing the bioscience unit of Sequenom four years ago, Agena has followed global growth by pushing into more clinical labs in China, as well as Europe.

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 group of regulatory authorities from around the world has proposed a new guidance for harmonizing the procedures for assessing medical devices, including IVDs.

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.

The firm anticipates receiving regulatory approval from the CFDA for its first three products by the end of the year, including one for lung cancer.

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.

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