Idylla BRAF Mutation Test

7 BRAF mutations in codon 600

~90 minutes assay turnaround time

< 2 minutes hands-on time

Only 1 slice of FFPE tissue required

Highly sensitive & standardized

Suitable for any lab

Idylla BRAF Mutation Test (CE-IVD)

A0010/6

The fully automated Idylla^TM BRAF Mutation Test covers BRAF V600E, E2, D, K, R and M mutation with a sensitivity of 1% of mutant in wild type background in FFPE samples with an excellent concordance to reference methods of >95%.

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Specimen requirements

One of the biggest challenges in oncology biomarker testing is the ability to obtain samples of sufficient size and quality. With the Idylla^TM System only a minimal amount of sample is needed

1x 5 μm FFPE tissue section -> 50-600 mm²
1x 10 μm FFPE tissue section -> 25-300 mm²
Neoplastic cells ≥50% - if less, macrodissection is required

Rapid BRAF mutation tests in patients with advanced melanoma: comparison of immunohistochemistry, Droplet Digital PCR, and the Idylla Mutation Platform.

Bisschop et al. - Melanoma Research - 2018

The Idylla^TM BRAF Mutation Test was compared to ddPCR, IHC, and Sanger Sequencing for testing BRAF V600 mutation. BRAF results were 100% concordant between Idylla, ddPCR, and Sanger Sequencing.

Multicenter evaluation of a novel automated rapid detection system of BRAF status in formalin-fixed, paraffin-embedded tissues

Schiefer et al. - J Mol Diagn. - May 2016

Multicenter evaluation of the Idylla^TM BRAF Mutation Assay compared to each testing site's standard of care testing method. BRAF results were concordant in 96.9% of samples tested. After discordant analysis, concordance was increased to 98.57%.

Idylla Oncology Assays

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