FDA approves Therascreen KRAS RGQ PCR Kit (Qiagen) for use with Colorectal Cancer patients

The FDA has given marketing approval for the Therascreen KRAS RGQ PCR Kit, from Qiagen, to provide guidance on the use of Erbitux (cetuximab) as a treatment in patients with metastatic Colorectal Cancer. The Therascreen KRAS RGQ PCR Kit is a molecular diagnostic kit for detection of 7 somatic mutations in the KRAS gene using real-time PCR on the Rotor-Gene Q 5plex HRM Instrument. Studies have shown that KRAS mutation testing can better define which metastatic colorectal cancer patients will benefit from treatment with epidermal growth factor receptor (EGFR) inhibiting monoclonal antibodies, such as panitumumab and cetuximab. The Therascreen KRAS kit is the second assay approved by the FDA for use on the Rotor-Gene Q MDx. Earlier in 2012, Qiagen's Artus Infl A/B RG RT-PCR for the detection of Influenza A/B was cleared for use on Rotor-Gene Q MDx, with the instrument also receiving FDA 510(k) clearance at the same time.