QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received approval by the U.S. Food and Drug Administration (FDA) to market the therascreen 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.