BRAF+ melanoma
What makes it different, makes it vulnerable

BRAF mutation testing: the different tests

Whilst not an exhaustive list, the table below provides details of the available tests for identifying BRAF mutations. Regarding next generation sequencing; although this isn’t available as a testing kit, for laboratories with sequencing technologies available this is an alternative to the below.


Method, instrumentation

Regulatory status

Analytical sensitivity LOD

BRAF mutations detected

THxIDTM- BRAF1 (bioMérieux, Inc.)

Real-time PCR,
ABI7500 FastDx (open)



5% mutation level for V600E and K

V600E and V600K


cobas® 4800 BRAF V6003

(Roche Diagnostics)

Real-time PCR,
Cobas 4800




5% mutation level for V600E

V600E (V600K and V600D possibly by cross reactivity)

therascreen BRAF RGQ PCR Kit4


Real-time PCR,
Rotor-Gene Q HDx 5plex HRM instrument



1.87% for V600E

4.3% for V600K

V600E, V600E complex, V600D, V600K, V600R


therascreen BRAF Pyro Kit5


Pyromark Q24 System



Not established

Codon 600: V600A, V600E, V600G, V600M, Codons 464-469: G464E, G464V, G466E, G466V, G469A, G469E, G469V


INFINITI BRAF Assay (AutoGenomics, Inc.)6

INFINITI Analyzer, INFINITI Plus Analyzer


Not available

BRAF V600A, V600D, V600E, V600KRM

FoundationOne CDx (Foundation Medicine, Inc.)7

NGS, multiple instruments



≤ 2.0% allele fraction for BRAF V600E and K

BRAF V600E, V600K, plus other genes

a Not a comprehensive list.

CE-IVD, Conformité Européene In Vitro Diagnostics (devices); FDA, US Food and Drug Administration; LOD, limit of detection; PCR, polymerase chain reaction.

  1. THxID™-BRAF [package insert]. Marcy-l’Etoile, France: bioMérieux, Inc.; 2013.
  2. FDA. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). Updated August 2, 2019. Accessed August 29, 2019.
  3. Roche Diagnostics. cobas® 4800 BRAF V600 Mutation Test. Accessed August 28, 2019.
  4. QIAGEN. Therascreen BRAF RGQ PCR Kit CE. Accessed August 28, 2019.
  5. QIAGEN. Therascreen BRAF Pyro Kit. The Netherlands. Accessed August 28, 2019.
  6. AutoGenomics, Inc. INFINITI® BRAF Assay. Directional package insert. February 2017.,PackageInsertforBRAF.pdf. Accessed September 6, 2019.
  7. Foundation Medicine, Inc. FoundationOne CDx. Technical information. Accessed September 4, 2019