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125P - Comparison of different testing methods for detection of BRAF V600 mutation in metastatic melanoma

Presentation Number
125P
Lecture Time
17:10 - 17:10
Speakers
  • Javier Hernandez-Losa (Barcelona, ES)
Session Name
Location
Foyer La Scene, Paris Marriott Rive Gauche, Paris, France
Date
05.03.2018
Time
17:10 - 18:00
Authors
  • Javier Hernandez-Losa (Barcelona, ES)
  • Yolanda Ruano (Madrid, ES)
  • Inmaculada Trigo Sanchez (Sevilla, ES)
  • Rosa Somoza (Barcelona, ES)
  • Berta Ferrer (Barcelona, ES)
  • Francisco Garcia Verdes-Montenegro (Madrid, ES)
  • Marta Urech (Madrid, ES)
  • Santiago Ramon Y Cajal (Barcelona, ES)
  • Juan Jose Rios Martin (Sevilla, ES)
  • Jose Luis Rodriguez-Peralto (Madrid, ES)

Abstract

Background

Cobas® 4800 BRAF V600 Mutation Test is a CE-marked and FDA-approved in vitro diagnostic assay used to detect metastatic melanoma patients eligible for treatment with BRAF inhibitors. The aim of the study is to compare the performance of two additional commercial kits to assess BRAF mutations in this context

Methods

A total of 247 Metastatic melanoma specimens were tested for BRAF V600 mutations at three laboratories (Vall d´Hebron, 12 de Octubre and Virgen Macarena Hospitals) with the COBAS® BRAF V600 V1 (Roche), Idylla BRAF (Biocartis) and COBAS® BRAF/NRAS V2 (Roche) kits. Overall (OPA) Positive (PPA) and Negative (NPA) percent agreements were determined between the cobas V1 test and the other assays. We also analyzed the sensitivity and specificity of each assay used in this study

Results

BRAF mutations were detected in 35.2% (87/247), 44.5% (110/247) and 42.9% (106/247) of samples by COBAS® BRAF V600 V1, Idylla and COBAS V2 kits respectively. Similar ratios of invalid results were observed in the 3 different technologies (1.2%, 1.6% and 1.6% respectively). Comparing COBAS V1 with other methods we obtained OPA 90%, PPA 79.6% and NPA 99.2% by Idylla and OPA 90%, PPA 80.3% and NPA 98.5% by COBAS V2 test. Finally, Idylla vs COBAS V2 showed OPA 96%, PPA 95.4% and NPA 97%. Sensitivity and Specificity for each assay in this global comparison were also calculated showing [82.8-100] by COBAS V1, [99-97.8] by Idylla and [98.1-97.8] by COBAS V2. Additionally, COBAS V2 test detected other BRAF non-V600 mutations (2 K601E and 1 G466A/V or G469A/R/V) and also NRAS mutations (2 NRAS G12X, 2 NRAS G13X and 41NRAS Q61X).

Conclusions

Both methodologies COBAS V2 and Idylla have a good performance to detect BRAF V600 mutations in metastatic melanoma samples with a high concordance between them. Both techniques compared with COBAS V1 detect more mutant BRAF V600 cases with High Sensitivity and Specificity. Finally, COBAS V2 detects more mutation out of V600 in BRAF and NRAS genes that allow managing those patients for potential different therapies.

Legal entity responsible for the study

Vall d´Hebron Institute Research

Funding

Has not received any funding

Disclosure

F. Garcia Verdes-Montenegro and M. Ulrech: Employee of Roche-Farma. All authors have declared no conflicts of interest.

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