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QIAGEN Launches new Automated Modular Testing Platform for Molecular Diagnostics

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QIAGEN N.V. has launched its QIAsymphony RGQ system. The automated platform has been specifically designed to address the fast-growing molecular diagnostics market, particularly for applications in “Profiling“ and “Personalized Healthcare“*. It is said to be the only modular system that covers entire laboratory workflows from the initial sample preparation to the final result.

The QIAsymphony RGQ can thereby provide its users with an unprecedented level of flexibility: Customers can use the new platform not only to run several existing QIAGEN tests, but also to develop and conduct their own PCR-based assays.

The QIAsymphony RGQ system is approved for in-vitro diagnostic use in Europe and launches with several molecular assays for the detection of viruses such as HIV and Hepatitis, as well as a specific test panel for transplantation medicine.

All of these products from QIAGEN’s artus product range have been already validated for clinical use in connection with the new system. Numerous other products will complement the existing test portfolio over the next months. These products will include tests for biomarkers such as KRAS, EGFR or PI3K in personalized healthcare applications, assays for the detection of influenza viruses, as well as a dedicated women’s health panel. This will allow diagnostic and research access to the broadest commercially available PCR-based assay portfolio in the marketplace.

According to QIAGEN, the system also allows customers to run custom laboratory developed tests (LDT) which can be validated for clinical use. In molecular diagnostics, laboratory developed tests account for about 40 percent of the global market volume and for an even higher share of all existing test parameters. Facing stricter requirements from regulatory bodies such as the U.S. Food and Drug Administration (FDA), this sector shows signs of a growing demand for standardized and clinically proven systems for the development of custom PCR-based assays. The company says that with the QIAsymphony RGQ, developers and users of such tests gain access to instruments and reagents that match the highest quality and functionality standards for clinical applications. To date, there are more than 200 such applications that are compatible with the new QIAsymphony RGQ platform.

“The launch of our QIAsymphony RGQ is a very important milestone in further expanding our leading position in molecular diagnostics”, said Peer Schatz, QIAGEN’s CEO. “The integrated and validated system was designed to meet both current and future needs of molecular diagnostic labs. We will continue to complement the system not only by expanding the existing assay portfolio, but also by adding further unique performance features.”

Future expansions that have been already announced by the company include the integration of the Pyrosequencing detection technology and the capability to detect multiple molecular targets in a single test run, known as Multiplexing.

With an increase of 14 percent, QIAGEN’s automation business has seen a strong revenue growth in the second quarter of 2010. Instrument sales thereby also add to long-term reagent and consumable sales, which account for 85 percent of the company’s business. QIAGEN has already registered a significant amount of pre-orders for the QIAsymphony RGQ system.

The QIAsymphony RGQ is composed of three modules: the award winning “QIAsymphony SP” for sample preparation, the new “QIAsymphony AS” for assay setup, and QIAGEN’s real-time PCR detection platform “Rotor-Gene Q”. Its features include continuous sample loading and the ability to run different tests for each sample. These features address a critical requirement in “Profiling” and “Personalized Healthcare” applications, where laboratories typically process a variety of different samples such as blood or tissue and have to test them for different molecular targets.