A new generation of companion diagnostics: cobas BRAF, KRAS and EGFR mutation detection tests

Barbara Angulo, Fernando Lopez-Rios, David Gonzalez

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

The cobas® (Roche) portfolio of companion diagnostics in oncology currently has three assays CE-marked for in vitro diagnostics. Two of these (EGFR and BRAF) are also US FDA-approved. These assays detect clinically relevant mutations that are correlated with response (BRAF, EGFR) or lack of response (KRAS) to targeted therapies such as selective mutant BRAF inhibitors in malignant melanoma, tyrosine kinases inhibitor in non-small cell lung cancer and anti-EGFR monoclonal antibodies in colorectal cancer, respectively. All these assays are run on a single platform using DNA extracted from a single 5 µm section of a formalin-fixed paraffin-embedded tissue block. The assays provide an ‘end-to-end’ solution from extraction of DNA to automated analysis and report on the cobas z 480. The cobas tests have shown robust and reproducible performance, with high sensitivity and specificity and low limit of detection, making them suitable as companion diagnostics for clinical use.
Original languageEnglish
Pages (from-to)517-524
Number of pages8
JournalExpert review of molecular diagnostics
Volume14
Issue number5
Early online date21 May 2014
DOIs
Publication statusPublished - Jun 2014

Keywords

  • BRAF mutations
  • cobas 480
  • colorectal cancer
  • companion diagnostics
  • EGFR mutations
  • KRAS mutations
  • malignant melanoma
  • molecular pathology
  • non-small-cell lung cancer

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