cobas 4800 BRAF V600 Mutation Test

From the manufacturer

Quoted verbatim from the manufacturer’s published product page. IVDmap did not write or verify this text.

• The cobas 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas 4800 System, and is intended to be used as an aid in selecting melanoma patients for treatment with the targeted therapies listed in the table below, in accordance with the approved therapeutic product labeling:TherapeuticTherapeutic IndicationTest ResultZELBORAF (vemurafenib)BRAF V600EMutation DetectedCOTELLIC…

  Roche DiagnosticsTechnology PlatformManufacturer Page2026-10-29

• The cobas BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melano

  Roche DiagnosticsQualitative Or QuantitativeManufacturer Page2026-10-06

• Two external run controls are provided and the wild-type allele serves as an internal, full process control.Specimen PreparationFFPET specimens are processed and genomic DNA isolated using the cobas D

  Roche DiagnosticsCategory L1Manufacturer Page2026-10-06