QIAGEN Receives FDA Approval for therascreen® EGFR RGQ PCR Kit as a Companion Diagnostic for Lung Cancer Patients

QIAGEN N.V. announced it has received approval by the U.S. Food and Drug Administration (FDA) to market thetherascreen EGFR test as a companion diagnostic to guide the use of Boehringer Ingelheim's new targeted therapy, GILOTRIFTM (afatinib), for treatment of metastatic NSCLC in patients whose tumors have certain EGFR gene mutations. More than 200,000 new lung cancer cases are diagnosed every year in the United States, with NSCLC accounting for approximately 85% of cases, leading to an estimated 160,000 deaths.

The therascreen EGFR test enables doctors to identify EGFR mutation-positive patients eligible for treatment with GILOTRIFTM (afatinib). The FDA approval of the therascreen EGFR test marks a further milestone in the global expansion of QIAGEN's Personalized Healthcare franchise - and adds a third FDA-approved or cleared diagnostic kit to run on QIAGEN's efficient Rotor-Gene Q MDx. Approximately 120,000 metastatic NSCLC patients each year in the U.S. could benefit from testing for EGFR mutations, a total potential testing market of about $35 million, according to QIAGEN estimates.

"We are very pleased to receive approval to market our therascreen EGFR test in the United States, a successful outcome from our collaboration with Boehringer Ingelheim. QIAGEN's companion diagnostics are transforming patient care and extending lives around the world by providing personalized genomic information to guide treatment decisions," said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. "The U.S. launch of the therascreen EGFR test adds to our growing menu of FDA-approved diagnostics running on the Rotor-Gene Q MDx, a real-time PCR platform in our revolutionary QIAsymphony family. Following the 2012 launch of our therascreen KRAS RGQ PCR Kit (therascreen KRAS test) in colorectal cancer, U.S. laboratories already have adopted this test for more than half of the KRAS testing volume."