QIAGEN Receives FDA Approval to Expand Use of EGFR Test in Lung Cancer

GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)-- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has approved a PMA Supplement expanding the labelling claim of the therascreen^® EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s VIZIMPRO^® (dacomitinib) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or an exon 21 L858R mutation. The therascreen EGFR RGQ PCR kit is now approved as a companion diagnostic to guide the use of three FDA-approved therapies, including also GILOTRIF^® (Afatinib) from Boehringer Ingelheim and Iressa^® (Gefitinib) from AstraZeneca. It is registered in more than 40 countries globally. This was a project governed under an agreement between QIAGEN and Pfizer.

“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.”

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