Gen-Probe Incorporated has launched in Europe the ELUCIGENE KRAS.BRAF kit, a highly sensitive, single-tube assay designed for the simultaneous quantitative detection of seven common KRAS mutations and the V600E BRAF mutation. The CE-marked assay provides valuable information regarding mutation status that can help clinicians determine the most appropriate treatment course for patients with metastatic colorectal cancer.
Treating metastatic colorectal cancer with anti-epidermal growth factor receptor (anti-EGFR) antibody inhibitors such as cetuximab and panitumumab has been shown to increase survival over treatment by chemotherapy alone. However, the therapy is ineffective in patients whose tumours demonstrate a KRAS or BRAF mutation. The ELUCIGENE KRAS.BRAF assay can help clinicians identify patients who will not benefit from anti-EGFR therapies, thereby reducing unnecessary expense and risk of toxic exposure. Indeed, the European Medicines Agency (EMA) approval for the two major anti-EGFR therapies, Vectibix and Erbitux, is contingent on testing for KRAS mutations prior to treatment.
Designed for simplicity and ease of use, the ELUCIGENE KRAS.BRAF test is a single-tube, ARMS (Amplification Refractory Mutation System)-PCR based fluorescent assay that is performed on ABI genetic analyzers for high throughput and rapid analysis. The simultaneous detection of KRAS and BRAF mutations reduces laboratory workload, analysis time and the potential for sample mix-up. Minimal hands-on time is required. Since all reagents are supplied premixed, performing the test requires only the addition of patient DNA. The test is highly sensitive, achieving a 1% detection sensitivity of mutant sequence in a normal background.
The ELUCIGENE KRAS.BRAF kit is validated for use on DNA extracted from formalin fixed paraffin embedded (FFPE) tissue samples. As FFPE derived DNA is often highly degraded, the kit includes a separate amplification control to ensure sufficient DNA is present prior to running the KRAS.BRAF test. This increases reproducibility and performance quality.
Source: Gen-Probe, Inc