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Product Watch: EntroGen KRAS, NRAS Mutation Analysis Kits


EntroGen this week announced the availability of expanded colorectal cancer screening products.

EntroGen K-Ras and N-Ras Mutation Analysis kits have been updated to include coverage for exon 2, 3, and 4 mutations in both genes. The company has obtained a CE IVD mark for these products.

The importance of mutations in exons 3 and 4 of KRAS and 2, 3, and 4 of NRAS were demonstrated in a randomized, multicenter phase 3 study published in 2013, where researchers from Amgen identified them as markers of innate resistance to Vectibix (panitumumab) in addition to the already known exon 2 mutations in KRAS.

Following the publication of this study, Amgen issued new guidelines for prescribing this drug for treatment of metastatic colorectal cancer. The newly expanded real-time PCR kits now cover all known mutations in codons 12, 13, 59, 61, 117, and 146 of the KRAS and NRAS genes, as well as the BRAF V600E mutation, providing a comprehensive screening tool that has superior sensitivity and turnaround time than those offered by NGS platforms, EntroGen said. The products have been validated on various real-time PCR instrument models, the company added.