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QIAGEN N.V. (QGEN) Launches CE- IVD Marked Tests for Companion Diagnostics

10/4/2010 2:23:03 PM

Hilden, Germany – October 04, 2010 – QIAGEN today announced the launch of several tests for cancer companion diagnostics, CE-marked with the Rotor-Gene® Q thermocycler (EGFR) and the PyroMark® pyrosequencing system (EGFR, NRAS, KRAS, BRAF). The new tests are used in personalized healthcare of cancer by identifying certain mutations in these particular genes, which then help clinicians to select and tailor the most appropriate treatment.

The kits are offered as CE-IVD marked therascreen tests in Europe as well as globally for research-use only (RUO), with the CE-marked therascreen pyrosequencing kits available beginning in December 2010.

The new offering expands QIAGEN’s portfolio of companion diagnostics in personalized healthcare; many more kits are currently in development and will be launched over the coming months.

The PCR-based kits can also be used in combination with the highly flexible QIAsymphony RGQ instrument that allows automation of the complete workflow from sample preparation and assay setup through to detection with the Rotor-Gene Q thermocycler. In the near future, pyrosequencing kits will also be automated with the QIAsymphony series.

QIAGEN’s diagnostic kits help to make personalized healthcare a reality: understanding the individual differences in the human genome helps physicians select and tailor treatments for their patients and is beneficial for the individual patient, while reducing costs for the healthcare system.

Find out more about the kits at


QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. QIAGEN employs more than 3,500 people in over 30 locations worldwide. Further information about QIAGEN can be found at

* – Test kits and the RGQ instrument are not currently available in the US for in-vitro diagnostic use. Consult your local QIAGEN representative to determine availability of the various test kits in your country for in vitro diagnostic use.

Contact: Global: Dr Marc Egelhofer QIAGEN GmbH +49-2103-29-11741 e-mail:

US: Cassie Knapp QIAGEN +1-240-686-7686 e-mail:

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