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QIAGEN N.V. (Nasdaq: QGEN) announced submission of its therascreen EGFR RGQ PCR Kit (therascreen EGFR test) to the U.S. Food and Drug Administration (FDA) as a proposed companion diagnostic to guide treatment with afatinib, a new investigational oncology compound developed by Boehringer Ingelheim. Afatinib has been accepted for filing and granted Priority Review by the FDA as a proposed treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who havewith an epidermal growth factor receptor (EGFR) mutation detected by an FDA-approved test.
QIAGEN submitted a Premarket Approval (PMA) application for use of the therascreen EGFR test to determine which NSCLC patients would be potentially eligible for treatment with afatinib. The companion diagnostic was developed in collaboration with Boehringer Ingelheim. In September 2012, the proposed drug also has been submitted to the European Medicines Agency (EMA). A version of the therascreen EGFR test has already been CE-marked and is available for diagnostic use in Europe. In late 2011, the test has also received regulatory approval in Japan, the world’s second largest market for Personalized Healthcare.
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