# cobas 4800 BRAF V600 Mutation Test

Source: https://onco.cc/drugs/cobas-4800-braf-v600/  
OnCo record `cobas-4800-braf-v600` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The BRAF test for melanoma approved as companion to vemurafenib in 2011 and to cobimetinib with vemurafenib in 2016.

## Summary

Roche Molecular Systems' cobas 4800 BRAF V600 Mutation Test was approved on 17 August 2011 (PMA P110020) as the companion diagnostic for vemurafenib in BRAF V600E melanoma. A supplement on 7 November 2016 added cobimetinib with vemurafenib for V600E or V600K melanoma.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: cobas 4800 BRAF V600 Mutation Test
- Modality: Real-time PCR companion diagnostic test (BRAF V600, melanoma tissue)
- Mechanism: Detects BRAF V600 mutations in DNA from melanoma tissue.
- Approvals: US 2011: Companion diagnostic for vemurafenib in BRAF V600E melanoma; US 2016: Companion diagnostic for cobimetinib with vemurafenib (V600E or V600K)

## Sources

- FDA PMA P110020: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110020
- FDA: List of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

## Connected records

- drugs: [Cobimetinib](https://onco.cc/drugs/cobimetinib/), [THxID BRAF Kit](https://onco.cc/drugs/thxid-braf/), [Vemurafenib](https://onco.cc/drugs/vemurafenib/)
- biomarkers: [BRAF V600E (and V600K)](https://onco.cc/biomarkers/braf-v600e/)
- cancers: [Melanoma](https://onco.cc/cancers/melanoma/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/)
- targets: [BRAF](https://onco.cc/targets/braf/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/)

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