FDA extends indication for Therascreen EGFR RGQ PCR Kit in non-small cell lung cancer.- Qiagen.

Qiagen announced that the FDA has approved a PMA supplement extending the indications for use of the Therascreen EGFR RGQ PCR Kit as a companion diagnostic to guide the use of Boehringer Ingelheim's targeted therapy Gilotrif (afatinib) for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with non-resistant epidermal growth factor receptor (EGFR) mutations. The approval extends the labeling claim to include detection of EGFR mutations L681Q, G719X and S768I to aid the identification of NSCLC patients for whom Gilotrif (afatinib) is indicated.

Comment: 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. Testing for EGFR mutations is believed to be the largest segment in companion diagnostics for personalized medicine.