The Idylla™ KRAS Mutation Test, performed on the Biocartis Idylla™ system, is an in vitro diagnostic test for the qualitative detection of mutations in codons 12, 13, 59, 61, 117, 146 of the KRAS oncogene. The Idylla™ KRAS Mutation Test directly liberates DNA from FFPE tissue of human colorectal cancer for subsequent real-time PCR amplification and detection.
The clinical validation study comparing the Idylla™ KRAS Mutation Test with a real-time PCR based reference method showed an agreement of 96.7% (95% CI 93.0% - 98.5%) for codons 12 and 13.
Idylla™ system and the Idylla™ KRAS Mutation Test are currently only sold in countries accepting the CE certification. For product availability in your country visit https://biocartis.com/order.