{ "ProductData": { "ID": "RTD000801", "ProductType": "Others", "BrandName": "CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody", "ProductNameAddition": "", "RegulatoryDisclaimer1": "For in vitro diagnostic use.", "DisclaimerGroup1": "IVD", "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ "Formalin-Fixed Paraffin-Embedded Tissue (FFPET)" ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "1E2", "ControlTissue": [ "Breast" ], "ISOtypes": "IgG", "Species": [ "Rabbit" ], "StainLocalization": [ "Nucleus" ], "ProductNameGlobal": "Progesterone Receptor 1E2 CONFIRM" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Product_RTD000801_im_en.jpg", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeID": "130", "StructureNodeStatus": "Active", "NodeName": "CONFIRM" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeID": "073-00", "StructureNodeStatus": "Active", "NodeName": "Immunohistochemistry (IHC)" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "05-0002", "StructureNodeStatus": "Active", "NodeName": "IHC Primary Antibodies" }, { "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": "08-00-00", "StructureNodeStatus": "Active", "NodeName": "Breast cancer" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeID": "14-00-00", "StructureNodeStatus": "Active", "NodeName": "Gynecology" }, { "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" }, { "StructureSystemIdentifier": "Indications", "StructureSystemName": "Indications", "NodeID": "107", "StructureNodeStatus": "Active", "NodeName": "Women's Health" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "05278392001", "MaterialDescription": "CONFIRM ANTI-PR (1E2) 250", "RegisteredProductName": "CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody", "GTIN": "04015630972203", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "790-4296", "PackSizePIM360": "250 tests", "PackSizeDescPIM360": "Not Available", "MaterialAnnotation": "", "ReadyForUse": "true", "OrderInformation": "" }, { "MaterialNum": "05277990001", "MaterialDescription": "CONFIRM ANTI-PR (1E2)", "RegisteredProductName": "CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody", "GTIN": "04015630972180", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "790-2223", "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": "RTD001009", "BrandName": "iVIEW DAB 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": "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": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "410", "StructureGroupPath": "VENTANA", "StructureGroupName": "VENTANA", "StructureNodeStatus": "Active" } ] }, { "ProductID": "RTD001185", "BrandName": "ultraView Universal DAB 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": "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": "660", "StructureGroupPath": "ultraView", "StructureGroupName": "ultraView", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "410", "StructureGroupPath": "VENTANA", "StructureGroupName": "VENTANA", "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" } ] }, { "ProductID": "INS_6476", "BrandName": "BenchMark ULTRA PLUS", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "9570", "StructureGroupPath": "Histology->Systems / Digital Products->Advanced Staining->BenchMark ULTRA PLUS", "StructureGroupName": "BenchMark ULTRA PLUS", "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": "075-00", "StructureGroupPath": "In situ Hybridization (ISH)", "StructureGroupName": "In situ Hybridization (ISH)", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "073-00", "StructureGroupPath": "Immunohistochemistry (IHC)", "StructureGroupName": "Immunohistochemistry (IHC)", "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" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Name": "Intended Use", "Value": "CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal (IgG) Primary Antibody is intended for laboratory use in the qualitative detection of progesterone receptor (PR) antigen in sections of formalin-fixed, paraffin-embedded tissue on a VENTANA automated slide stainer with VENTANA detection kits and ancillary reagents. CONFIRM anti-PR (1E2) is directed against an epitope present on human progesterone receptor protein located in the nucleus of PR positive normal and neoplastic cells.

CONFIRM anti-PR (1E2) is indicated as an aid in the management, prognosis, and prediction of hormone therapy for breast carcinoma.

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

This antibody is intended for in vitro diagnostic (IVD) use.", "Language": "en", "Country": "XG", "Code": "Intended Use" }, { "Name": "Background Information", "Value": "CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody (CONFIRM anti-PR (1E2) antibody) is a rabbit monoclonal antibody that recognizes the A, and B isoforms of human progesterone receptor (PR). The immunogen was developed from a synthetic peptide identified as an area of potential high antigenicity common to progesterone receptor A and B forms. The peptide was synthesized and covalently bound to keyhole limpet hemocyanin to further increase antigenicity. CONFIRM anti-PR (1E2) antibody has been shown to react with 60 kD, 87 kD and 110 kD proteins from T47D cells via Western blotting. The protein sizes are in agreement with the predicted molecular weight of progesterone receptor forms A, B and C.¹

PR is a nuclear hormone receptor encoded by a single gene (PGR).^1,2 PR activity is regulated by the closely related nuclear hormone receptor estrogen receptor (ER). The coordinated actions of ER and PR drive normal mammary gland development and are required for differentiation and proliferation in the adult breast epithelium.^1,2,3

Breast cancer is the leading cause of cancer related death in women.⁴ The diagnosis and treatment of the disease relies on early detection coupled with a reliable strategy to stratify patients into the appropriate therapy based on prognostic and predictive factors.^5,6 The established diagnostic workup of breast cancer is a combination of physical examination, imaging and pathological assessment.⁵

ER is one of the paradigm tumor markers for the management of breast cancer patients. Clinical guidelines and best practice recommendations stipulate that ER status should be evaluated in every case of primary invasive breast cancer to identify patients most likely to respond to endocrine forms of therapy.^5,6 Selective estrogen receptor modulators block estrogen mediated cancer growth by mitigating ER hyperactivity and are used as endocrine therapy for patients overexpressing the receptor.^6,7

In practice, nearly half of ER positive patients fail to respond to endocrine treatment; a phenomenon linked to malignant transformation of the receptor in cancerous lesions.⁸ PR overexpression can be used to further characterize the breast tumor and predict therapeutic response by acting as a reporter to evaluate the functional status of ER.^8,9 In 1975 it was hypothesized that the overexpression of PR can be a predictive marker for response to endocrine therapy.⁸ Subsequent studies confirmed the predictive and prognostic value of PR.^10,11 A higher level of PR expression is an indicator of better response to endocrine therapy.¹⁰

The detection of PR is a cornerstone in the management of patients with invasive breast carcinoma.^5,6,9 Guidelines and best practice recommendations emphasize that immunohistochemistry (IHC) is the preferred method to detect PR in breast cancer.⁹

Therefore, the IHC-based detection of PR with CONFIRM anti-PR (1E2) antibody may be used as an aid in the management, prognosis and prediction of therapy outcome of breast carcinoma.

1. Kariagina A, Aupperlee MD, Haslam SZ. Progesterone receptor isoform functions in normal breast development and breast cancer. Crit Rev Eukaryot Gene Expr. 2008;18(1):11-33.
2. Grimm SL, Hartig SM, Edwards DP. Progesterone Receptor Signaling Mechanisms. J Mol Biol. 2016;428(19):3831-3849.
3. Tanos T, Rojo L, Echeverria P, et al. ER and PR signaling nodes during mammary gland development. Breast Cancer Res. 2012;14(4):210.
4. Torre LA, Islami F, Siegel RL, et al. Global Cancer in Women: Burden and Trends. Cancer Epidemiol Biomarkers Prev. 2017;26(4):444-457.
5. Cardoso F, Kyriakides S, Ohno S, et al. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019.
6. Goldhirsch A, Winer EP, Coates AS, et al. Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013. Ann Oncol. 2013;24(9):2206- 2223.
7. Swaby RF, Sharma CG, Jordan VC. SERMs for the treatment and prevention of breast cancer. Rev Endocr Metab Disord. 2007;8(3):229-239.
8. Horwitz KB, McGuire WL. Predicting response to endocrine therapy in human breast cancer: a hypothesis. Science. 1975;189(4204):726-727.
9. Hammond ME, Hayes DF, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. Arch Pathol Lab Med. 2010;134(6):907-22.
10. Bardou VJ, Arpino G, Elledge RM, et al. Progesterone receptor status significantly improves outcome prediction over estrogen receptor status alone for adjuvant endocrine therapy in two large breast cancer databases. J Clin Oncol. 2003;21(10):1973-1979.
11. Ravdin PM, Green S, Dorr TM, et al. Prognostic significance of progesterone receptor levels in estrogen receptor-positive patients with metastatic breast cancer treated with tamoxifen: results of a prospective Southwest Oncology Group study. J Clin Oncol. 1992;10(8):1284-1291.", "Language": "en", "Country": "XG", "Code": "Background Information" }, { "Name": "Principle", "Value": "CONFIRM anti-PR (1E2) antibody binds to PR in formalin-fixed, paraffin embedded (FFPE) tissue sections. The specific antibody can be localized by either a biotin conjugated secondary antibody formulation that recognizes rabbit immunoglobulins, followed by the addition of a streptavidin horseradish peroxidase (HRP) conjugate (iVIEW DAB Detection Kit) or a secondary antibody-HRP conjugate (ultraView Universal DAB Detection Kit). The specific antibody-enzyme complex is then visualized with a precipitating enzyme reaction product.

Clinical cases should be evaluated within the context of the performance of appropriate controls. Ventana Medical Systems, Inc. (Ventana) recommends the inclusion of a positive tissue control fixed and processed in the same manner as the patient specimen (for example, a weakly positive breast carcinoma or uterus). In addition to staining with CONFIRM anti-PR (1E2) antibody, a second slide should be stained with CONFIRM Negative Control Rabbit Ig. For the test to be considered valid, the positive control tissue should exhibit nuclear staining of the tumor cells or uterine glands and stroma. These components should be negative when stained with CONFIRM Negative Control Rabbit Ig. In addition, it is recommended that a negative tissue control slide (for example, a PR negative breast carcinoma) be included for every batch of samples processed and run on the BenchMark IHC/ISH instrument. This negative tissue control should be stained with CONFIRM anti-PR (1E2) antibody to ensure that the antigen enhancement and other pretreatment procedures did not create false positive staining.", "Language": "en", "Country": "XG", "Code": "Principle" }, { "Name": "Content", "Value": "CONFIRM anti-PR (1E2) antibody (Cat. No. 790-2223) contains sufficient reagent for 50 tests.

One 5 mL dispenser CONFIRM anti-PR (1E2)antibody contains approximately 5 μg of a rabbit monoclonal antibody directed against human PR antigen.
CONFIRM anti-PR (1E2) antibody (Cat. No. 790-4296) contains sufficient reagent for 250 tests.

One 25 mL dispenser CONFIRM anti-PR (1E2) antibody contains approximately 25 μg of a rabbit monoclonal antibodydirected against human PR antigen.

The antibody is diluted in Tris-HCl with carrier protein, and 0.1% ProClin 300, a preservative. There is trace (∼ 0.2%) fetal calf serum of U.S. origin from the stock solution.

Specific antibody concentration is approximately 1 μg/mL. There is no known non-specific antibody reactivity observed in this product.

CONFIRM anti-PR (1E2) antibody is a rabbit monoclonal antibody produced as a 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 General Limitations.", "Language": "en", "Country": "XG", "Code": "Content" }, { "Name": "Product Purpose", "Value": "CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal (IgG) Primary Antibody is intended for laboratory use in the qualitative detection of progesterone receptor (PR) antigen in sections of formalin-fixed, paraffin-embedded tissue on a VENTANA automated slide stainer with VENTANA detection kits and ancillary reagents. CONFIRM anti-PR (1E2) is directed against an epitope present on human progesterone receptor protein located in the nucleus of PR positive normal and neoplastic cells.

CONFIRM anti-PR (1E2) is indicated as an aid in the management, prognosis, and prediction of hormone therapy for breast carcinoma.

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

This antibody is intended for in vitro diagnostic (IVD) use.", "Language": "en", "Country": "XG", "Code": "Product Purpose" } ] } } ] }