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Idylla™ NRAS-BRAF Mutation Test (CE-IVD)

About 5 percent of all metastatic colorectal tumors harbor mutations in exons 2, 3 and 4 of the NRAS oncogene. Idylla™ NRAS-BRAF Mutation Test detects NRAS and BRAF mutations directly from FFPE tissue sections in approx. 2 hours with less than 2 minutes hands-on time.

 

The Idylla™ NRAS-BRAF Mutation Test has obtained CE marking as an in vitro diagnostic (IVD) medical device.

Highly sensitive and standardized

The Idylla™ NRAS-BRAF Mutation Test, performed on the Biocartis Idylla™ system, is an in vitro diagnostic test for the qualitative detection of NRAS mutations in codons 12, 13, 59, 61, 117 and 146 of the NRAS oncogene, and BRAF mutations in codon 600. The Idylla™ NRAS-BRAF 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™ NRAS-BRAF Mutation Test with a sequencing-based reference method showed an overall agreement of 99.6% [98.1%-100%] and 100% [98.9%-100%] for mutations in the NRAS and BRAF gene, respectively.


Idylla™ NRAS-BRAF Mutation Test, running on the Idylla™ system, is available in countries accepting the CE marked IVD. For product availability in your country, visit https://biocartis.com/order.