FDA approves expanded use of Qiagen's EGFR test in lung cancer

Qiagen announced Friday that the FDA approved an expanded labelling claim for the therascreen EGFR RGQ PCR kit to allow its use as a companion diagnostic with Pfizer's Vizimpro (dacomitinib) for the first-line treatment of patients with non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or an exon 21 L858R mutation.

The companion diagnostic, which helps determine if a patient's lung cancer cells express EGFR mutations, initially gained FDA approval in 2013 for use concurrently with Boehringer Ingelheim's Gilotrif (afatinib) for patients with late-stage NSCLC. The labelling claim was extended earlier this year to include detection of three additional EGFR mutations to guide Gilotrif therapy in the first-line setting. The test is also approved to guide use of AstraZeneca's Iressa (gefitinib) in the treatment of patients with advanced or metastatic NSCLC.

Jonathan Arnold, Qiagen's head of oncology and precision diagnostics, remarked that "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."