China State FDA

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.

The firm registered the Novaprep HQ+ Orange vial as a class I device with the US FDA, while the CFDA approved the Novaprep system for non-gynecological testing. 

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.