KRAS Mutation Test Approved

The US Food and Drug Administration has approved Qiagen's Therascreen KRAS RGQ PCR Kit as a companion diagnostic to Erbitux (cetuximab), reports Medscape Medical News. At the same time, FDA approved a new indication for Erbitux, saying it could be used along with irinotecan, 5-fluorouracil, and leucovorin to treat metastatic colorectal cancer patients who have tumors that express EGFR and have wild-type KRAS. The Qiagen assay detects KRAS mutations and can help determine which patients may benefit from Erbitux therapy. "This test helps clinicians determine whether this specific treatment is an effective option," says Alberto Gutierrez, the director of the Office of In Vitro Diagnostic Device Evaluation and Safety at FDA in a statement.