{ "ProductData": { "ID": "RTD001234", "ProductType": "Others", "BrandName": "VENTANA® PD-L1 (SP263) Assay", "ProductNameAddition": "CE-IVD", "RegulatoryDisclaimer1": "For in vitro diagnostic use.", "DisclaimerGroup1": "IVD", "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ "Formalin-Fixed Paraffin-Embedded Tissue (FFPET)" ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "SP263", "ControlTissue": [ "Placenta" ], "ISOtypes": "", "Species": [ "Rabbit" ], "StainLocalization": [ "Cytoplasm", "Membrane" ], "ProductNameGlobal": "PD-L1 SP263 CE IVD US Export VENTANA" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Product_RTD001234_im_en.jpg", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "05-0002", "StructureNodeStatus": "Active", "NodeName": "IHC Primary Antibodies" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeID": "410", "StructureNodeStatus": "Active", "NodeName": "VENTANA" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeID": "073-00", "StructureNodeStatus": "Active", "NodeName": "Immunohistochemistry (IHC)" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeID": "080-00", "StructureNodeStatus": "Active", "NodeName": "Pathology Lab" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeID": "19-00-00", "StructureNodeStatus": "Active", "NodeName": "Oncology" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "NodeID": "23-00-00", "StructureNodeStatus": "Active", "NodeName": "Lung cancer" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeID": "20-00-00", "StructureNodeStatus": "Active", "NodeName": "Pulmonology" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeID": "030", "StructureNodeStatus": "Active", "NodeName": "Companion diagnostics" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeID": "010", "StructureNodeStatus": "Active", "NodeName": "Histopathology" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "NodeID": "99-00-00", "StructureNodeStatus": "Inactive", "NodeName": "" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "NodeID": "99-00-00", "StructureNodeStatus": "Inactive", "NodeName": "" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "NodeID": "15-000-00", "StructureNodeStatus": "Active", "NodeName": "Primary Antibody" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeID": "080", "StructureNodeStatus": "Active", "NodeName": "BenchMark" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "07419821001", "MaterialDescription": "VENTANA PD-L1 (SP263) CE IVD US Export", "RegisteredProductName": "VENTANA PD-L1 (SP263) Assay", "GTIN": "04015630976478", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "741-4905", "PackSizePIM360": "50 tests", "PackSizeDescPIM360": "Not Available", "MaterialAnnotation": "", "ReadyForUse": "true", "OrderInformation": "" } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "INS_2099", "BrandName": "BenchMark ULTRA", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "2300", "StructureGroupPath": "Histology->Systems / Digital Products->Advanced Staining->BenchMark ULTRA", "StructureGroupName": "BenchMark ULTRA", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "080", "StructureGroupPath": "BenchMark", "StructureGroupName": "BenchMark", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "080-00", "StructureGroupPath": "Pathology Lab", "StructureGroupName": "Pathology Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "010", "StructureGroupPath": "Histopathology", "StructureGroupName": "Histopathology", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "073-00", "StructureGroupPath": "Immunohistochemistry (IHC)", "StructureGroupName": "Immunohistochemistry (IHC)", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "075-00", "StructureGroupPath": "In situ Hybridization (ISH)", "StructureGroupName": "In situ Hybridization (ISH)", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" } ] }, { "ProductID": "INS_2580", "BrandName": "BenchMark GX", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "6151", "StructureGroupPath": "Histology->Systems / Digital Products->Advanced Staining->BenchMark GX", "StructureGroupName": "BenchMark GX", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "080", "StructureGroupPath": "BenchMark", "StructureGroupName": "BenchMark", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "080-00", "StructureGroupPath": "Pathology Lab", "StructureGroupName": "Pathology Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "010", "StructureGroupPath": "Histopathology", "StructureGroupName": "Histopathology", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" } ] }, { "ProductID": "RTD001078", "BrandName": "OptiView DAB IHC Detection Kit", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "05-0001", "StructureGroupPath": "Tissue->IHC Detection Systems", "StructureGroupName": "IHC Detection Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "073-00", "StructureGroupPath": "Immunohistochemistry (IHC)", "StructureGroupName": "Immunohistochemistry (IHC)", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "080-00", "StructureGroupPath": "Pathology Lab", "StructureGroupName": "Pathology Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "010", "StructureGroupPath": "Histopathology", "StructureGroupName": "Histopathology", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "667", "StructureGroupPath": "OptiView", "StructureGroupName": "OptiView", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "080", "StructureGroupPath": "BenchMark", "StructureGroupName": "BenchMark", "StructureNodeStatus": "Active" } ] }, { "ProductID": "PID00000381", "BrandName": "uPath PD-L1 (SP263) image analysis, NSCLC", "ProductNameAddition": "", "ReferenceType": "Software", "Classification": [ { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "23-00-00", "StructureGroupPath": "Lung cancer", "StructureGroupName": "Lung cancer", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "19-00-00", "StructureGroupPath": "Oncology", "StructureGroupName": "Oncology", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "20-00-00", "StructureGroupPath": "Pulmonology", "StructureGroupName": "Pulmonology", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "080-00", "StructureGroupPath": "Pathology Lab", "StructureGroupName": "Pathology Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "450", "StructureGroupPath": "uPath", "StructureGroupName": "uPath", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "012", "StructureGroupPath": "Digital pathology", "StructureGroupName": "Digital pathology", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "051", "StructureGroupPath": "Digital solutions", "StructureGroupName": "Digital solutions", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "60-000-00", "StructureGroupPath": "Electronic Services", "StructureGroupName": "Electronic Services", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "410", "StructureGroupPath": "VENTANA", "StructureGroupName": "VENTANA", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "703", "StructureGroupPath": "VENTANA DP", "StructureGroupName": "VENTANA DP", "StructureNodeStatus": "Active" } ] }, { "ProductID": "INS_6320", "BrandName": "VENTANA® DP 200 slide scanner", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "9433", "StructureGroupPath": "Histology->Systems / Digital Products->Digital pathology and Workflow->VENTANA DP 200", "StructureGroupName": "VENTANA DP 200", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "410", "StructureGroupPath": "VENTANA", "StructureGroupName": "VENTANA", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "080-00", "StructureGroupPath": "Pathology Lab", "StructureGroupName": "Pathology Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "012", "StructureGroupPath": "Digital pathology", "StructureGroupName": "Digital pathology", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "200-00", "StructureGroupPath": "Whole Slide Imaging", "StructureGroupName": "Whole Slide Imaging", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "051", "StructureGroupPath": "Digital solutions", "StructureGroupName": "Digital solutions", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "703", "StructureGroupPath": "VENTANA DP", "StructureGroupName": "VENTANA DP", "StructureNodeStatus": "Active" } ] }, { "ProductID": "RTD001173", "BrandName": "ULTRA Cell Conditioning (ULTRA CC1)", "ProductNameAddition": "", "ReferenceType": "Auxilliary", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "05-0016", "StructureGroupPath": "Tissue->ISH Bulk Solutions", "StructureGroupName": "ISH Bulk Solutions", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "05-0005", "StructureGroupPath": "Tissue->IHC Bulk Solutions", "StructureGroupName": "IHC Bulk Solutions", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "080-00", "StructureGroupPath": "Pathology Lab", "StructureGroupName": "Pathology Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "010", "StructureGroupPath": "Histopathology", "StructureGroupName": "Histopathology", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "95-000-00", "StructureGroupPath": "Auxiliaries", "StructureGroupName": "Auxiliaries", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "080", "StructureGroupPath": "BenchMark", "StructureGroupName": "BenchMark", "StructureNodeStatus": "Active" } ] }, { "ProductID": "RTD000939", "BrandName": "Hematoxylin II", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "05-0027", "StructureGroupPath": "Tissue->Research Reagents Ancillaries", "StructureGroupName": "Research Reagents Ancillaries", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "05-0017", "StructureGroupPath": "Tissue->ISH Counterstains", "StructureGroupName": "ISH Counterstains", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "05-0007", "StructureGroupPath": "Tissue->IHC Counterstains", "StructureGroupName": "IHC Counterstains", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "05-0006", "StructureGroupPath": "Tissue->IHC Diluents", "StructureGroupName": "IHC Diluents", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "073-00", "StructureGroupPath": "Immunohistochemistry (IHC)", "StructureGroupName": "Immunohistochemistry (IHC)", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "075-00", "StructureGroupPath": "In situ Hybridization (ISH)", "StructureGroupName": "In situ Hybridization (ISH)", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "080-00", "StructureGroupPath": "Pathology Lab", "StructureGroupName": "Pathology Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "010", "StructureGroupPath": "Histopathology", "StructureGroupName": "Histopathology", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "080", "StructureGroupPath": "BenchMark", "StructureGroupName": "BenchMark", "StructureNodeStatus": "Active" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Name": "Storage Conditions (Product)", "Value": "Upon receipt and when not in use, store at 2-8°C. Do not freeze.", "Language": "en", "Country": "XG", "Code": "Storage Conditions (Product)" }, { "Name": "Intended Use", "Value": "Reportez-vous à la notice du test VENTANA PD-L1 (SP263) correspondante pour l'utilisation prévue détaillée de ce produit.
Remarque: L'utilisation de ce diagnostic avec les traitements indiqués peut ne pas être approuvée dans tous les pays. Veuillez consulter votre revendeur Roche représentant pour les approbations locales.", "Language": "fr", "Country": "XG", "Code": "Intended Use" }, { "Name": "Content", "Value": "VENTANA PD-L1 (SP263) Assay contains sufficient reagent for 50 tests.

One 5 mL dispenser of VENTANA PD-L1 (SP263) Assay contains approximately 8 μg of a rabbit monoclonal antibody.
The antibody is diluted in Tris-HCI with carrier protein and 0.10% ProClin 300, a preservative.

Specific antibody concentration is approximately 1.61 μg/mL. There is no known non-specific antibody reactivity observed in this product.

VENTANA PD-L1 (SP263) Assay is a recombinant rabbit monoclonal antibody produced as purified cell culture supernatant.

Refer to the appropriate VENTANA detection kit method sheet for detailed descriptions of: Principle of the Procedure, Material and Methods, Specimen Collection and Preparation for Analysis, Quality Control Procedures, Troubleshooting, Interpretation of Results, and Limitations.", "Language": "en", "Country": "XG", "Code": "Content" }, { "Name": "Principle", "Value": "VENTANA PD-L1 (SP263) Assay is a rabbit monoclonal primary antibody which binds to PD-L1 in FFPE tissue sections. This antibody can be visualized using OptiView DAB IHC Detection Kit (Cat. No. 760-700 / 06396500001). Refer to the respective method sheet for further information.", "Language": "en", "Country": "XG", "Code": "Principle" }, { "Name": "Background Information", "Value": "VENTANA PD-L1 (SP263) Assay is an immunohistochemical assay utilizing an anti-PD-L1 rabbit monoclonal primary antibody (VENTANA PD-L1 (SP263) to recognize the programmed death-ligand 1 (PD-L1) protein.

PD-L1 is a transmembrane protein that down regulates immune responses through binding to its two receptors programmed death-1 (PD-1) and B7-1.1 PD-1 is an inhibitory receptor expressed on T-cells following T-cell activation, which is sustained in states of chronic stimulation such as in chronic infection or cancer.2 Binding of PD-L1 with PD-1 inhibits T-cell proliferation, cytokine production, and cytolytic activity, leading to the functional inactivation or exhaustion of T-cells.2 B7.1 is a molecule expressed on antigen presenting cells and activated T-cells. PD-L1 binding to B7.1 on T-cells and antigen presenting cells can mediate downregulation of immune responses, including inhibition of T-cell activation and cytokine production.3 PD-L1 expression has been observed in immune cells and malignant cells4,5 and aberrant expression of PD-L1 on malignant cells has been reported to impede anti-tumor immunity, resulting in immune evasion.2,5 Therefore, interruption of the PD-L1/PD-1 pathway represents an attractive strategy to reinvigorate tumor-specific T-cell immunity suppressed by the expression of PD-L1 in the tumor microenvironment.

The association between PD-L1 expression in TC or tumor-infiltrating immune cells (IC) and clinical benefit with PD-L1/PD-1 pathway inhibitors has been reported across multiple cancers.

1. Keir ME, Butte MJ, Freeman GJ, et al. PD-1 and its ligands in tolerance and immunity. Annu Rev Immunol 2008; 26:677-704.
2. Blank C, Mackensen A. Contribution of the PD-L1/PD-1 pathway to T-cell exhaustion: an update on implications for chronic infections and tumor evasion. Cancer Immunol Immunother 2007; 56(5):739-745.
3. Butte MJ, Keir ME, Phamduy TB, et al. Programmed death-1 ligand 1 interacts specifically with the B7-1 costimulatory molecule to inhibit T-cell responses. Immunity 2007; 27(1):111-122.
4. Dong H, Zhu G, Tamada K, Chen L. B7-H1, a third member of the B7 family, co- stimulates T-cell proliferation and interleukin-10 secretion. Nat Med 1999; 5(12):1365-1369.
5. Massard C, Gordon MS, Sharma S, et al. Safety and efficacy of durvalumab (MEDI4736), an anti-programmed cell death ligand-1 immune checkpoint inhibitor, in patients with advanced urothelial bladder cancer. J Clin Oncol 2016; 34(26):3119- 3125.", "Language": "en", "Country": "XG", "Code": "Background Information" }, { "Name": "Product Purpose", "Value": "Reportez-vous à la notice du test VENTANA PD-L1 (SP263) correspondante pour l'utilisation prévue détaillée de ce produit.
Remarque: L'utilisation de ce diagnostic avec les traitements indiqués peut ne pas être approuvée dans tous les pays. Veuillez consulter votre revendeur Roche représentant pour les approbations locales.", "Language": "fr", "Country": "XG", "Code": "Product Purpose" } ] } } ] }

VENTANA® PD-L1 (SP263) Assay

CE-IVD

IVD For in vitro diagnostic use.
VENTANA PD-L1 (SP263) Assay, non-small cell lung cancer (NSCLC), urothelial carcinoma, bladder cancer
Guiding immunotherapy decisions

VENTANA PD-L1 predictive assays identify patients who are most likely to respond to specific therapies, generating results you can trust so that you can make timely diagnostic decisions and therapeutic choices. We support your expertise by providing you with the tools that you need to successfully implement these assays into your laboratory and interpret them proficiently.

Empowering pathologists to answer PD-L1 questions

VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying:

 

  • Non-small cell lung cancer (NSCLC) patients eligible for treatment with IMFINZI® (durvalumab)
  • NSCLC patients eligible for treatment with KEYTRUDA® (pembrolizumab)
  • Non-squamous NSCLC patients most likely to benefit from OPDIVO® (nivolumab)
  • NSCLC patients eligible for treatment with LIBTAYO® (cemiplimab)
  • NSCLC patients eligible for treatment with TECENTRIQ® (atezolizumab)

 

VENTANA PD-L1 (SP263) Assay further benefits patients by:

 

  • Providing robust PD-L1 staining in both tumour cells (TC) and tumour-infiltrating immune cells (IC)*
  • Allowing optimal lung tissue management through PD-L1 testing of archived unstained slides within 12 months

* IC staining with this assay is not used to assess PD-L1 status for IMFINZI, KEYTRUDA, OPDIVO, LIBTAYO or TECENTRIQ in NSCLC.

VENTANA PD-L1 (SP263) Assay is intended for the qualitative detection of the programmed death ligand 1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), tissue stained with OptiView DAB IHC Detection Kit on a BenchMark IHC/ISH instrument.

This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.

This product is intended for in vitro diagnostic (IVD) use.

The assay is intended for identifying patients who may benefit from therapy as shown in Table 1. Please refer to the respective drug labeling for clinical recommendations pertaining to PD-L1 expression.

Table 1. Therapy and associated indication.

Afficher le tableau complet

Table 1. Therapy and associated indication.

Indication for use Therapy PD-L1 expression
NSCLC IMFINZI® ≥ 1% TC 
KEYTRUDA® ≥50% TC 
≥1% TC
LIBTAYO® ≥50% TC
TECENTRIQ® ≥50% TC
Non-squamous NSCLC OPDIVO® ≥1%, ≥5% and ≥10%

Description

Detailed Specifications

Référence produit

Compatible Instruments

...
    ...

    Documents techniques

    Accéder aux documents disponibles dans votre pays

    Vous êtes actuellement sur le site Web mondial. Modifiez la localisation pour afficher les options de langues ou accédez à eLabDoc, le référentiel des documents des produits.
    error errorMessage
    Un problème est survenu lors du chargement de cette section.
    Veuillez recharger cette page ou réessayer plus tard.