For Healthcare professionals
outside the US

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^a	Method, instrumentation	Regulatory status	Analytical sensitivity LOD	*BRAF* mutations detected
THxID^TM- BRAF¹ (bioMérieux, Inc.)	Real-time PCR, ABI7500 FastDx (open)	FDA² CE-IVD	5% mutation level for V600E and K	V600E and V600K
cobas^® 4800 BRAF V600³ (Roche Diagnostics)	Real-time PCR, Cobas 4800 (closed)	FDA² CE-IVD	5% mutation level for V600E	V600E (V600K and V600D possibly by cross reactivity)
therascreen BRAF RGQ PCR Kit⁴ (QIAGEN)	Real-time PCR, Rotor-Gene Q HDx 5plex HRM instrument (open)	CE-IVD	1.87% for V600E 4.3% for V600K	V600E, V600E complex, V600D, V600K, V600R
therascreen BRAF Pyro Kit⁵ (QIAGEN)	Pyrosequencing, Pyromark Q24 System (open)	CE-IVD	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	CE-IVD	Not available	BRAF V600A, V600D, V600E, V600KRM
FoundationOne CDx (Foundation Medicine, Inc.)⁷	NGS, multiple instruments	FDA²	≤ 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.

REFERENCES:

THxID™-BRAF [package insert]. Marcy-l’Etoile, France: bioMérieux, Inc.; 2013.
FDA. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). https://www.fda.gov/media/119249/download. Updated August 2, 2019. Accessed August 29, 2019.
Roche Diagnostics. cobas® 4800 BRAF V600 Mutation Test. https://diagnostics.roche.com/global/en/products/params/cobas-4800-braf-v600-mutation-test.html. Accessed August 28, 2019.
QIAGEN. Therascreen BRAF RGQ PCR Kit CE. https://www.qiagen.com/no/shop/detection-solutions/personalized-healthcare/therascreen-braf-rgq-pcr-kit-ce/#productdetails. Accessed August 28, 2019.
QIAGEN. Therascreen BRAF Pyro Kit. The Netherlands. https://www.qiagen.com/ch/shop/detection-solutions/personalized-healthcare/therascreen-braf-pyro-kit/#productdetails. Accessed August 28, 2019.
AutoGenomics, Inc. INFINITI® BRAF Assay. Directional package insert. February 2017. http://www.autogenomics.com/englishpi/EM-34047E(English)-H,PackageInsertforBRAF.pdf. Accessed September 6, 2019.
Foundation Medicine, Inc. FoundationOne CDx. Technical information. https://assets.ctfassets.net/vhribv12lmne/6Rt6csmCPuaguuqmgi2iY8/2fe839f0e9075cf4a047bf241374e6af/F1CDx.Label.Technical_Info_Final_July_2019.pdf. Accessed September 4, 2019

Disclaimer: This is an international website on the role of mutated BRAF in melanoma and BRAF testing and is intended for healthcare professionals outside the US. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.

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