Therascreen EGFR RGQ Plasma PCR Kit regulatory update

FDA approved a PMA from Qiagen for therascreen EGFR RGQ PCR Kit as a companion diagnostic for AstraZeneca’s Iressa gefitinib to treat advanced or metastatic non-small cell lung cancer (NSCLC). The agency approved Iressa last week for the indication in patients whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. AZ plans to launch the EGFR tyrosine kinase inhibitor in the U.S. this week. ...