FDA approves test as companion diagnostic for treatment of NSCLC

July 19, 2013

QIAGEN has received approval from 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, Gilotrif (afatinib), for treatment of metastatic non-small-cell lung cancer (NSCLC) in patients whose tumors have certain EGFR gene mutations. Approval of the therascreen EGFR test follows an FDA priority review of Gilotrif, and the drug's labeling requires the use of an FDA-approved test to select EGFR mutation-positive patients for the therapy. Gilotrif is indicated for NSCLC patients with the most common mutations in the EGFR gene, which are EGFR exon 19 deletions and exon 21 L858R substitution mutations.

The therascreen EGFR test enables doctors to identify EGFR mutation-positive patients eligible for treatment with Gilotrif. Its approval adds a third FDA-approved or cleared diagnostic kit to run on QIAGEN's efficient Rotor-Gene Q MDx. More than 200,000 new lung cancer cases are diagnosed every year in the United States, with NSCLC accounting for approximately 85% of cases. Some 120,000 metastatic NSCLC patients each year in the U.S. could benefit from testing for EGFR mutations. Read the FDA press release announcing the approval of Gilotrif.

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