Biocartis’ KRAS Mutation Test Receives CE-IVD Marking
Product News Jun 24, 2015
Biocartis has announced the launch of its CE-IVD Idylla™ KRAS Mutation Test, a sample-to-result test for the fast, accurate and reproducible detection of 21 relevant mutations in the KRAS oncogene.
The Idylla™ KRAS Mutation Test is the first fully-automated CE-IVD test available for routine use that detects all clinically relevant driver mutations of the KRAS oncogene in tissue of colorectal cancers (CRC) at a sensitivity of 5% as recommended according to ESMO, NCCN, and the recently issued CAP/AMP/ASCO guidelines.
Unique to the Idylla™ KRAS Mutation Test is its ability 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.
Validation studies and pre-market trials on more than 500 mCRC patient samples have demonstrated the excellent accuracy of the Idylla™ KRAS Mutation Test. During the validation study, the Idylla™ KRAS Mutation Test detected 8% more mutations than the reference test. Between-lab reproducibility studies showed a 100% agreement between all participating sites, demonstrating that the Idylla™ KRAS Mutation Test is easy to implement and highly standardized.
The Idylla™ KRAS Mutation Test runs on the Idylla™ platform and provides accurate and actionable results in an unprecedented timeframe of approximately two hours. Hands-on time is less than two minutes as the formalin-fixed, paraffin embedded (FFPE) tissue is directly inserted into the Idylla™ cartridge without any prior deparaffinization or other pre-processing steps.
Dr. Alberto Bardelli, Director of the Laboratory of Molecular Genetics, Institute for Cancer Research and Treatment, Torino, Italy, commented: “Biocartis has crafted an innovative KRAS test that offers exactly what is currently needed in the field: the Idylla KRAS Mutation Test has an excellent sensitivity and detects 21 mutations in all of the relevant codons of KRAS exons 2, 3 and 4. These unique features, combined with ease of use and short turnaround time, are expected to be of benefit to any lab.”
The Idylla™ KRAS Mutation Test is the second test launched by Biocartis and a cornerstone in a set of highly standardized and sensitive tests around metastatic colorectal cancer. A similar extended NRAS panel, which can be combined with KRAS for the detection on an extended panel of 40 RAS mutations in combination with BRAF and EGFR492 mutations, is currently in development.