A new generation of companion diagnostics: cobas BRAF, KRAS and EGFR mutation detection tests. (June 2014)

• Record Type: Journal Article
• Authors: Angulo, Barbara; Lopez-Rios, Fernando; Gonzalez, David
• Is Part Of: Expert review of molecular diagnostics. Volume 14:Number 5(2014)
• Page Start: 517
• Page End: 524
• Publication Date: 2014-06
• Subjects: Molecular diagnosis -- Periodicals; 616.0758205
• DOI: 10.1586/14737159.2014.910120
• Languages: English
• ISSNs: 1473-7159

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <p>The cobas^® (Roche) portfolio of companion diagnostics in oncology currently has three assays CE-marked for <italic>in vitro</italic> diagnostics. Two of these (<italic>EGFR</italic> and <italic>BRAF</italic>) are also US FDA-approved. These assays detect clinically relevant mutations that are correlated with response (<italic>BRAF, EGFR</italic>) or lack of response (<italic>KRAS</italic>) 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.</p> </abstract>