Qiagen receives FDA approval to expand use of EGFR test in lung cancer

Qiagen (QGEN) announced that the 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 for first-line treatment of patients with non-small cell lung cancer with epidermal growth factor receptor, or 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 It is registered in more than 40 countries globally. This was a project governed under an agreement between QIAGEN and Pfizer (PFE).

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