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Idylla™ KRAS Mutation Test (CE-IVD)

 

About 45 percent of all metastatic colorectal tumors harbor mutations in exons 2, 3 and 4 of the KRAS oncogene. Idylla™ KRAS Mutation Test detects KRAS mutations directly from FFPE tissue sections in approx. 2 hours with less than 2 minutes hands-on time.

 

  • Directly from FFPE tissue sections
  • Approx. 2 hours total turnaround time from sample to result
  • Less than 2 minutes hands-on time
  • Detection of 21 relevant KRAS mutations in codons 12 and 13 (exon 2), codons 59 and 61 (exon 3) and codons 117 and 146 (exon 4)
  • Highly sensitive & standardized
  • Contamination-controlled design

 

The Idylla™ KRAS Mutation Test has achieved CE-IVD marking.

 

Highly sensitive and standardized

 

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.