FDA Extends Approval for Qiagen NSCLC Test as CDx to Boehringer Ingelheim's Gilotrif

The FDA has granted Qiagen a Premarket Approval (PMA) supplement extending the authorization of Qiagen’s therascreen ® EGFR RGQ PCR Kit as a companion diagnostic for Boehringer Ingelheim's targeted cancer treatment Gilotrif ® (afatinib).The new indication expands the indications for therascreen to include detection of epidermal growth factor receptor (EGFR) mutations L681Q, G719X, and S768I, in order to identify non-small-cell lung cancer (NSCLC) patients for whom Gilotrif is indic