therascreen KRAS Assay Package CE

This QIAGEN assay is a CE-marked IVD for the qualitative detection of clinically relevant KRAS mutations in DNA from tumor specimens, intended to support molecular oncology testing. It is supplied with controls and instructions for use and is optimized for compatible real-time PCR platforms and laboratory workflows.

The assay targets 7 somatic mutations in codons 12 and 13 of the KRAS gene. KRAS encodes a protein that plays a critical role in the epidermal growth factor receptor (EGFR) signaling cascade, and mutations can affect how the protein stimulates downstream pathways. Detection combines two technologies: ARMS (Amplification Refractory Mutation System), which achieves allele- or mutation-specific PCR amplification, and Scorpions, bifunctional molecules containing a primer linked to a probe for real-time fluorescence detection. The workflow is a two-step procedure consisting of a control assay to assess total DNA in a sample, followed by a mutation assay for the presence or absence of mutated DNA.

According to the manufacturer, KRAS is mutated in approximately 30% of all cancer types, with high frequencies reported in colorectal cancer (35%) and lung (18%) cancer. KRAS mutation testing can help define which metastatic colorectal cancer patients may benefit from treatment with EGFR-inhibiting monoclonal antibodies such as panitumumab and cetuximab. Somatic mutations in the KRAS gene may also be indicated as a potential predictive biomarker to guide treatment decisions for certain NSCLC therapies.