{ "ProductData": { "ID": "PID00000378", "ProductType": "Digital", "BrandName": "uPath HER2 (4B5) image analysis, Breast", "ProductNameAddition": "", "RegulatoryDisclaimer1": "See country-specific product labeling for regulatory status.", "DisclaimerGroup1": "Country Specific Labeling", "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "HER2 (4B5) ALGO BREAST" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/uPathHER2-4B5.jpg", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "StructureNodeStatus": "valid", "NodeName": "Breast cancer", "NodeID": "08-00-00" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "StructureNodeStatus": "valid", "NodeName": "Oncology", "NodeID": "19-00-00" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "StructureNodeStatus": "valid", "NodeName": "Gynecology", "NodeID": "14-00-00" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "StructureNodeStatus": "valid", "NodeName": "Pathology Lab", "NodeID": "080-00" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "StructureNodeStatus": "valid", "NodeName": "uPath", "NodeID": "450" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "StructureNodeStatus": "valid", "NodeName": "Digital pathology", "NodeID": "012" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "StructureNodeStatus": "valid", "NodeName": "Digital solutions", "NodeID": "051" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "StructureNodeStatus": "valid", "NodeName": "Electronic Services", "NodeID": "60-000-00" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "999-00" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "09134425001", "MaterialDescription": "HER2 (4B5) algo breast IVD - 1.x", "RegisteredProductName": "uPath HER2 (4B5) image analysis, Breast", "GTIN": "", "ProductCategoryText": "Electronic Services", "OldMaterialNumber": "", "PackSizePIM360": "Not Available", "PackSizeDescPIM360": "Not Available", "MaterialAnnotation": "", "ReadyForUse": "", "OrderInformation": "" }, { "MaterialNum": "09076204001", "MaterialDescription": "HER2 (4B5) algo breast RUO - 1.x", "RegisteredProductName": "uPath HER2 (4B5) image analysis, Breast", "GTIN": "07613336190418", "ProductCategoryText": "Electronic Services", "OldMaterialNumber": "", "PackSizePIM360": "Not Available", "PackSizeDescPIM360": "Not Available", "MaterialAnnotation": "", "ReadyForUse": "", "OrderInformation": "" } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "RTD001084", "BrandName": "PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "05-0002", "StructureGroupPath": "Tissue->IHC Primary Antibodies", "StructureGroupName": "IHC Primary Antibodies", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "300", "StructureGroupPath": "PATHWAY", "StructureGroupName": "PATHWAY", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "073-00", "StructureGroupPath": "Immunohistochemistry (IHC)", "StructureGroupName": "Immunohistochemistry (IHC)", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "080-00", "StructureGroupPath": "Pathology Lab", "StructureGroupName": "Pathology Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "19-00-00", "StructureGroupPath": "Oncology", "StructureGroupName": "Oncology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "08-00-00", "StructureGroupPath": "Breast cancer", "StructureGroupName": "Breast cancer", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "14-00-00", "StructureGroupPath": "Gynecology", "StructureGroupName": "Gynecology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "010", "StructureGroupPath": "Histopathology", "StructureGroupName": "Histopathology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "030", "StructureGroupPath": "Companion diagnostics", "StructureGroupName": "Companion diagnostics", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "15-000-00", "StructureGroupPath": "Primary Antibody", "StructureGroupName": "Primary Antibody", "StructureNodeStatus": "valid" } ] }, { "ProductID": "INS_6320", "BrandName": "VENTANA DP 200 slide scanner", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "9433", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "410", "StructureGroupPath": "VENTANA", "StructureGroupName": "VENTANA", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "080-00", "StructureGroupPath": "Pathology Lab", "StructureGroupName": "Pathology Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "012", "StructureGroupPath": "Digital pathology", "StructureGroupName": "Digital pathology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "200-00", "StructureGroupPath": "Whole Slide Imaging", "StructureGroupName": "Whole Slide Imaging", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "051", "StructureGroupPath": "Digital solutions", "StructureGroupName": "Digital solutions", "StructureNodeStatus": "valid" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "The uPath HER2 (4B5) image analysis, Breast algorithm is an adjunctive computer-assisted tool that identifies HER2 on tumor cell membranes within a pathologist-annotated viable tumor region in images of formalin-fixed, paraffin- embedded neoplastic breast tissue.", "Country": "XG", "Code": "Intended Use", "Name": "Intended Use" } ] } } ] }

uPath HER2 (4B5) image analysis, Breast

Ready-to-use, fast, consistent and automated algorithm

uPath HER2 (4B5) image analysis, Breast, product image
uPath whole slide image analysis algorithms

An intelligent and advanced digital pathology solution requires artificial intelligence-based image analysis tools that empower pathologists to confidently and objectively assess whole tissue slide images.

The uPath HER2 (4B5) image analysis, Breast algorithm is an adjunctive computer-assisted tool that identifies HER2 positive tumor cell membrane within a pathologist-annotated viable tumor region in images of formalin-fixed, paraffin-embedded neoplastic breast tissue.

Elevate performance, alleviate laboratory demands

icon gear
Integrated and ready-to-use

 

Validated for use with the Roche HER2 (4B5) clone and Roche uPath enterprise software.

icon lightning
Quick and automated

 

Pathologist-trained image analysis algorithm quickly calculates HER2 score.

icon check
Accurate, consistent and confident

 

Actionable assessment of slide images that are objective and reproducible.

Digital pathology
Explore the benefits of the Roche uPath HER2 (4B5) image analysis, Breast algorithm
  • Enhanced accuracy with a pathologist-trained image analysis algorithm which results in objective and reproducible scoring of slide images scanned on VENTANA DP 200 slide scanner and stained with the Roche HER2 (4B5) clone
  • Fully embedded into  Roche uPath enterprise software to enable seamless viewing, aligning,  syncing, sharing, and reporting
  • Speed up time to results for user-defined regions of interest with whole slide analysis (WSA) and automated pre-computing of the slide image prior to pathologist assessment
  • Quickly calculates HER2 score
  • A clear visual overlay highlights positively stained membrane for easy reference
Digital pathology solution

Maximize the potential of your digital pathology laboratory

The Roche Digital Pathology solution comprises high-performance hardware, software and uPath whole slide image analysis algorithms, and works in integrated harmony with the full Roche diagnostic portfolio for an end-to-end experience that enhances pathology workflows. 

Registration Status

*CE-IVD marked. For Research Use Only in the US. Not for use in diagnostic procedures in the US.

Refer to the product-specific labeling for the regulatory status of the scanner and uPath. When Research Use Only products are used with IVD products, the integrated workflow will be for Research Use Only and cannot be used for diagnostic procedures.

Overview

Ordering Information

Technical Documents

Access Material Data Sheets, Certificates of Analysis, and other product documentation.

After clicking above, you will be redirected to eLabDoc, where you can choose your local country.
error errorMessage
Sorry, we couldn't find the content you are looking for
Please try again later