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.
Hospital Universitario Sanchinarro - Laboratorio de Dianas Terapeuticas, Centro Integral Oncologico Clara Campal C/Oña, 10. 28050, Madrid, Spain.
Barbara
B
Angulo
Fernando
F
Lopez-Rios
David
D
Gonzalez
D014408:Biomarkers, Tumor / Q000235:genetics*; D004252:DNA Mutational Analysis; D055088:Early Detection of Cancer / Q000379:methods*; D066246:ErbB Receptors / Q000235:genetics*; D006801:Humans; D009154:Mutation; D009369:Neoplasms / Q000175:diagnosis* / Q000235:genetics; D011518:Proto-Oncogene Proteins / Q000235:genetics*; D048493:Proto-Oncogene Proteins B-raf / Q000235:genetics*; D016283:Proto-Oncogene Proteins p21(ras); D018631:ras Proteins / Q000235:genetics*
D014408:Biomarkers, Tumor; C117307:KRAS protein, human; D011518:Proto-Oncogene Proteins; C512478:EGFR protein, human; D066246:ErbB Receptors; C482119:BRAF protein, human; D048493:Proto-Oncogene Proteins B-raf; D016283:Proto-Oncogene Proteins p21(ras); D018631:ras Proteins
BRAF mutations; EGFR mutations; KRAS mutations; cobas 480; colorectal cancer; companion diagnostics; malignant melanoma; molecular pathology; non-small-cell lung cancer