BRAFm+ Metastatic 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.

Test Technology and instrumentation Reg status Analytical sensitivity LOD BRAF mutations detected
Biomerieux ThxID BRAF1 Real-Time PCR ABI7500 FastDx
(opened)
FDA
CE-IVD
5% mutation level for V600E and K V600E and K
Roche Cobas4800 BRAF V6002 Real-Time PCR
Cobas 4800
(closed)
FDA
CE-IVD
5% mutation level for V600E V600E (V600 K and D possibly by cross reactivity)
Qiagene BRAF Therascrene RGQ PCR kit3 Real-Time PCR
Rotor-Gene Q Instrument
(opened)
CE-IVD 1.87% for V600E 4.3% for V600K V600E, V600Ec, V600D, V600K, V600R
Qiagene Therascreen BRAF Pyro Kit4 Pyrosequencing
Pyromark Q24 System
(opened)
RUO Not established Mutations in codon 600 in exon16 and codons 464-469 in exon 11 of BRAF gene
MelaCarta Sequenom5 Mass spec sequencing
Sequenom platform-
(opened)
RUO, ASR
(LDT)
10% BRAF G466E, G466A, G466V, G469S, G469E, G469A, G469V, G469R, L597Q, L597R, L597S, L597V, V600E, V600K, V600R, V600L plus other genes, high throughput method
  1. THxID™-BRAF test. BioMérieux, Inc. USA. Package insert: Available at: http://www.biomerieux-usa.com/upload/BRAF-package-insert-1.pdf. Last accessed January 2015.
  2. cobas® 4800 BRAF V600 Mutation Test, Roche Molecular Systems Inc. USA. Available at: http://molecular.roche.com/assays/Pages/cobas4800BRAFV600MutationTest.aspx. Last accessed January 2015.
  3. Therascreen KRAS RGQ PCR Kit. Qiagen, the Netherlands. Available at: https://www.qiagen.com/nl/shop/detection-solutions/personalized-healthcare/therascreen-kras-pyro-kit/#productdetails. Last accessed January 2015.
  4. Therascreen BRAF Pyro Kit. Qiagen, the Netherlands. Available at: https://www.qiagen.com/nl/shop/detection-solutions/personalized-healthcare/therascreen-braf-pyro-kit/#productdetails Last accessed January 2015.
  5. MelaCarta™ Panel, Sequenom Inc. USA. Available at: http://agenabio.com/wp-content/uploads/2015/05/51-20011R2.0-MelaCarta-Flyer_WEB.pdf. Last accessed November 2015.