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Idylla™ BRAF Mutation Test (CE-IVD)

 

About 50 percent of all melanomas harbor mutations in the BRAF oncogene. Idylla™ BRAF Mutation Test detects BRAF mutations directly from FFPE tissue sections in 90 minutes with less than 2 minutes hands-on time.

 

  • Detection of BRAF V600E, E2, D, K, R and M mutations
  • 90 minutes total turnaround time
  • Less than 2 minutes hands-on time
  • Directly from FFPE tissue sections
  • Highly sensitive & standardized
  • Contamination-controlled design

 

The Idylla™ BRAF Mutation Test has demonstrated excellent analytical sensitivity. It can detect BRAF V600E, E2, D, K, R and M mutations at an analytical sensitivity of 1% of mutant in wild type background in FFPE samples.

 

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

 

Highly sensitive and standardized

 

The Idylla™ BRAF Mutation Test has demonstrated excellent analytical sensitivity. It can detect BRAF V600E, E2, D, K, R and M mutations at an analytical sensitivity of 1% of mutant in wild type background in FFPE samples. Studies demonstrated excellent concordance with Illumina MiSeq deepsequencing technology (100%), with Roche’s Cobas® BRAF V600 Mutation Test (96.7%) and with CLIA laboratory PCR-based sequencing and Sequenom™ MassARRAY (98%). A clinical validation study comparing Idylla™ with Pyrosequencing showed 97.9% agreement between both assays.