Table 1.

cobas 4800 BRAF specifications and BRAFV600 isoform detection

Specifications and mutation detectioncobas 4800 BRAFV600 mutation test
ParameterRequirements
Clinical specimen requiredFFPET slide (≥5-μm section)
Limit of detection of FFPET5% mutant allelea
Minimal tumor content within specimen15%
DNA requirement within specimen125 ng
Mutation detection
V600 isoformAgreement with Sanger sequencing
V600E97.3%
V600K65.8%
Other V600Not establishedb

Abbreviation: FFPET, formalin-fixed paraffin-embedded tissue.

  • aCompared with 20% for Sanger sequencing.

  • bInsufficient sample size for assessment of V600D, V600E2, and V600R.