QIAGEN sought FDA approval for QIAGEN’s therascreen EGFR RGQ PCR Kit for NSCLC

QIAGEN N.V declared the U.S FDA’s approval of PMA supplement augmenting indications for use of QIAGEN’s therascreen EGFR RGQ PCR kit as a diagnostic to direct the use of  Boehringer Ingelheim’s targeted therapy GILOTRIF (afatinib) for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with non-resistant epidermal growth factor receptor (EGFR) mutations. The approval also testifies the labeling claim to include detection of EGFR mutations L681Q, G719X and S768I ascertaining NSCLC patients for whom GILOTRIF® (afatinib) is indicated. QIAGEN collaborates with other pharmaceutical and biotechnology companies to co-develop companion diagnostics divulging genetic abnormalities therefore offering in-depth guide enabling clinical decision- making on the use of drugs in cancer especially. QIAGEN is anticipating more than  5 FDA submissions and U.S launches in 2018.

Jonathan Arnold, Vice President and head of QIAGEN’s Partnering for Precision Diagnostics unit claimed “As precision medicine develops increasing sophistication to guide the use of medicines based on individual genomic variations, we are pleased to provide benefits to more lung cancer patients with these additional biomarkers in our clinically proven therascreen EGFR RGQ PCR Kit. Our collaboration with Boehringer Ingelheim, which led to FDA approvals of Gilotrif and our companion diagnostic in 2013, continues to improve personalized healthcare for patients around the world.”