A new generation of companion diagnostics: cobas BRAF, KRAS and EGFR mutation detection tests.
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.
['Angulo|Barbara|B|', 'Lopez-Rios|Fernando|F|', 'Gonzalez|David|D|']
D014408:Biomarkers, Tumor D004252:DNA Mutational Analysis D055088:Early Detection of Cancer D066246:ErbB Receptors D006801:Humans D009154:Mutation D009369:Neoplasms D011518:Proto-Oncogene Proteins D048493:Proto-Oncogene Proteins B-raf D016283:Proto-Oncogene Proteins p21(ras) D018631:ras Proteins
companion diagnostics EGFR mutations malignant melanoma colorectal cancer BRAF mutations KRAS mutations cobas 480 molecular pathology non-small-cell lung cancer