title: Profile of Ventana ALK (D5F3) companion diagnostic assay for non-small-cell lung carcinomas.
abstract: The development of several ALK inhibitors means that the importance of accurately identifying ALK-positive lung cancer has never been greater. Therefore, it is crucial that ALK testing assays become more standardized. The aim of this review is to comment on the recently FDA-approved VENTANA ALK (D5F3) Companion Diagnostic (CDx) Assay. This kit provides high sensitivity and specificity for the detection of ALK rearrangements and seamless integration into the laboratory workflow, with a fully automated analytical phase and fast interpretation. The use of controls increases the sensitivity and specificity and a dichotomous scoring approach enhances reproducibility.
authors.affiliation: a Laboratorio de Dianas Terapéuticas , Hospital Universitario HM Sanchinarro , Madrid , Spain.|b Faculty of Medicine , Universidad San Pablo-CEU , Madrid , Spain.
authors.forename: Esther
authors.initials: E
authors.lastname: Conde
authors.affiliation: a Laboratorio de Dianas Terapéuticas , Hospital Universitario HM Sanchinarro , Madrid , Spain.
authors.forename: Susana
authors.initials: S
authors.lastname: Hernandez
authors.affiliation: a Laboratorio de Dianas Terapéuticas , Hospital Universitario HM Sanchinarro , Madrid , Spain.|b Faculty of Medicine , Universidad San Pablo-CEU , Madrid , Spain.
authors.forename: Mario
authors.initials: M
authors.lastname: Prieto
authors.affiliation: a Laboratorio de Dianas Terapéuticas , Hospital Universitario HM Sanchinarro , Madrid , Spain.
authors.forename: Rebeca
authors.initials: R
authors.lastname: Martinez
authors.affiliation: a Laboratorio de Dianas Terapéuticas , Hospital Universitario HM Sanchinarro , Madrid , Spain.|b Faculty of Medicine , Universidad San Pablo-CEU , Madrid , Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Lopez-Rios
mesh_terms: D000077548:Anaplastic Lymphoma Kinase; D000911:Antibodies, Monoclonal / Q000276:immunology; D014408:Biomarkers, Tumor / Q000235:genetics / Q000276:immunology / Q000378:metabolism*; D002289:Carcinoma, Non-Small-Cell Lung / Q000378:metabolism* / Q000473:pathology; D006801:Humans; D007150:Immunohistochemistry / Q000379:methods / Q000592:standards; D008175:Lung Neoplasms / Q000378:metabolism* / Q000473:pathology; D025202:Molecular Diagnostic Techniques / Q000379:methods* / Q000592:standards; D011933:Reagent Kits, Diagnostic / Q000592:standards; D020794:Receptor Protein-Tyrosine Kinases / Q000235:genetics / Q000276:immunology / Q000378:metabolism*
chemical_list: D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor; D011933:Reagent Kits, Diagnostic; C000626173:ALK protein, human; D000077548:Anaplastic Lymphoma Kinase; D020794:Receptor Protein-Tyrosine Kinases
keywords: ALK; FISH; IHC; companion diagnostic; lung carcinoma