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QIAGEN Receives Approval for EGFR Test in Lung Cancer as Companion Diagnostic in Japan

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the Japanese Pharmaceuticals and Medical Device Agency (PMDA) has approved the therascreen® EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s VIZIMPRO® (dacomitinib) for EGFR gene mutation-positive, inoperable or recurrent non-small cell lung cancer. The therascreen®EGFR RGQ PCR Kit is registered in more than 40 countries globally. This marks the first companion diagnostic approval for QIAGEN in Japan.

“As precision medicine becomes the standard of care in oncology, we are pleased to provide benefits to more lung cancer patients with our clinically proven therascreen EGFR RGQ PCR Kit. Our collaboration with Pfizer has made great strides already and will continue to improve personalized healthcare for patients around the world,” said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics for QIAGEN. “In addition to detecting a comprehensive panel of EGFR mutations, the therascreen EGFR kit offers laboratories an efficient workflow on the Rotor-Gene Q MDx, the real-time PCR module in our widely-used QIAsymphony family of instruments.”

QIAGEN is a pioneer in Personalized Healthcare and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect genetic abnormalities to provide insights that guide clinical decision-making on the use of drugs in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from NGS to PCR for companion diagnostic development and has been the market leader in companion diagnostics working under master collaboration agreements with more than 25 pharmaceutical companies developing companion diagnostic tests for their drug candidates. For more details surrounding QIAGEN’s companion diagnostics and their claims please visit For additional information on Pfizer’s VIZIMPRO® (dacomitinib) please visit

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Last Updated: 16-Jan-2019