title: Profile of the Roche cobas® EGFR mutation test v2 for non-small cell lung cancer.
abstract: The discovery of driver mutations in non-small cell lung cancer (NSCLC) has led to the development of genome-based personalized medicine. Fifteen to 20% of adenocarcinomas harbor an epidermal growth factor receptor (EGFR) activating mutation associated with responses to EGFR tyrosine kinase inhibitors (TKIs). Individual laboratories' expertise and the availability of appropriate equipment are valuable assets in predictive molecular pathology, although the choice of methods should be determined by the nature of the samples to be tested and whether the detection of only well-characterized EGFR mutations or rather, of all detectable mutations, is required. Areas covered: The EGFR mutation testing landscape is manifold and includes both screening and targeted methods, each with their own pros and cons. Here we review one of these companion tests, the Roche cobas® EGFR mutation test v2, from a methodological point of view, also exploring its liquid-biopsy applications. Expert commentary: The Roche cobas® EGFR mutation test v2, based on real time RT-PCR, is a reliable option for testing EGFR mutations in clinical practice, either using tissue-derived DNA or plasma-derived cfDNA. This application will be valuable for laboratories with whose purpose is purely diagnostic and lacking high-throughput technologies.
authors.affiliation: a Department of Public Health , University of Naples Federico II , Naples , Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Malapelle
authors.affiliation: b Department of Biotechnology , Universitat Politècnica de València , Valencia , Spain.|c Department of Medical Oncology , Hospital General Universitario de Valencia , Valencia , Spain.|d Molecular Oncology Laboratory , Fundación Hospital General Universitario de Valencia , Valencia , Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Sirera
authors.affiliation: b Department of Biotechnology , Universitat Politècnica de València , Valencia , Spain.|c Department of Medical Oncology , Hospital General Universitario de Valencia , Valencia , Spain.|d Molecular Oncology Laboratory , Fundación Hospital General Universitario de Valencia , Valencia , Spain.
authors.forename: Eloísa
authors.initials: E
authors.lastname: Jantus-Lewintre
authors.affiliation: e Phase I-Early Clinical Trials Unit, Oncology Department , Antwerp University Hospital , Antwerp , Belgium.|f Center for Oncological Research (CORE) , Antwerp University , Antwerp , Belgium.
authors.forename: Pablo
authors.initials: P
authors.lastname: Reclusa
authors.affiliation: c Department of Medical Oncology , Hospital General Universitario de Valencia , Valencia , Spain.|d Molecular Oncology Laboratory , Fundación Hospital General Universitario de Valencia , Valencia , Spain.|g Department of Pathology , Universitat de València , Valencia , Spain.
authors.forename: Silvia
authors.initials: S
authors.lastname: Calabuig-Fariñas
authors.affiliation: c Department of Medical Oncology , Hospital General Universitario de Valencia , Valencia , Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Blasco
authors.affiliation: a Department of Public Health , University of Naples Federico II , Naples , Italy.
authors.forename: Pasquale
authors.initials: P
authors.lastname: Pisapia
authors.affiliation: e Phase I-Early Clinical Trials Unit, Oncology Department , Antwerp University Hospital , Antwerp , Belgium.|f Center for Oncological Research (CORE) , Antwerp University , Antwerp , Belgium.
authors.forename: Christian
authors.initials: C
authors.lastname: Rolfo
authors.affiliation: c Department of Medical Oncology , Hospital General Universitario de Valencia , Valencia , Spain.|d Molecular Oncology Laboratory , Fundación Hospital General Universitario de Valencia , Valencia , Spain.|h Department of Medicine , Universitat de València , Valencia , Spain.|i CIBERONC , Valencia , Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Camps
mesh_terms: D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000235:genetics*; D004252:DNA Mutational Analysis / Q000295:instrumentation / Q000379:methods; D066246:ErbB Receptors / Q000235:genetics*; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000235:genetics*; D009154:Mutation; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction / Q000295:instrumentation / Q000379:methods*; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000295:instrumentation / Q000379:methods*
chemical_list: D011933:Reagent Kits, Diagnostic; C512478:EGFR protein, human; D066246:ErbB Receptors
keywords: EGFR; TKIs; cobas®; companion diagnostic; liquid biopsy; mutation; resistance