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

作者：Angulo Barbara; Lopez Rios Fernando; Gonzalez David^*

来源：Expert Review of Molecular Diagnostics, 2014, 14(5): 517-524.

DOI：10.1586/14737159.2014.910120

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

The cobas (R) (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 mm 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.

• 出版日期2014-6