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Biocartis' KRAS Mutation Test Receives CE-IVD Mark

NEW YORK (GenomeWeb) – Biocartis today announced its Idylla KRAS Mutation Test has received CE-IVD marking. 

The Belgian company has launched the sample-to-result test for the detection of 21 relevant mutations in the KRAS oncogene. It is the first fully automated CE-IVD test available for routine use and detects all clinically relevant driver mutations of the KRAS oncogene in tissue of colorectal cancers at a 5 percent sensitivity rate, Biocartis said. 

According to the firm, the test is uniquely able to detect all relevant mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of the KRAS gene. It runs on Biocartis' PCR-based Idylla platform, which launched in September. The automated system is designed to work in any laboratory setting, enabling decentralized molecular testing, and generates result in between 40 minutes and 2.5 hours. 

Because formalin-fixed, paraffin-embedded tissue is inserted directly into the Idylla cartridge without the need for any pre-processing steps, the hands-on time required for the KRAS test is less than two minutes, Biocartis said.