Qiagen said today that it has registered its QIAsymphony SP instrument with China's State Food and Drug Administration.
The QIAsymphony SP fully automates assay sample preparation, and can handle an extensive variety of starting materials such as blood and tissue samples, with a wide range of input and output volumes and formats, Qiagen said.
The company added that more than 40 protocols to isolate, purify, and prepare DNA, RNA, and proteins have been optimized for use on the SP instrument.
QIAsymphony SP is one of three instruments that make up the company's QIAsymphony RGQ platform for automated, sample-to-answer molecular assays. The second component, the Rotor-Gene Q thermal cycler, received SFDA approval in September 2010. Qiagen said it expects the third component, the QIAsymphony AS module for assay setup, to receive SFDA approval by the end of the year.
The QIAsymphony RGQ platform is available for in vitro diagnostic use under the CE Mark with several commercial tests. It is not currently available in the US for IVD use, although the company has submitted a premarket approval application to the US Food and Drug Administration for a QIAsymphony KRAS test for use as a companion diagnostic with the metastatic colorectal cancer drug Erbitux (cetuximab).