For in vitro diagnostic use. Membrane Others HER-2 neu 4B5 PATHWAY IVD Breast Carcinoma PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody RTD001084 Rabbit 4B5 05 278 368 001 5 278 368 001 05278368001 5278368001 05278368001 PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONO PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody 04015630972197 Reagents, kits 790-2991 50 tests Not Available true Ventana Medical Systems, Inc.'s (Ventana) PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) is a rabbit monoclonal antibody intended for laboratory use for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue following staining on a BenchMark IHC/ISH instrument. It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (trastuzumab) or KADCYLA® (ado-trastuzumab emtansine) treatment is being considered.This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.This antibody is intended for in vitro diagnostic (IVD) use.Note: All of the patients in the Herceptin clinical trials were selected using a clinical trial assay. None of the patients in those trials were selected using PATHWAY anti-HER-2/neu (4B5). PATHWAY anti-HER-2/neu (4B5) was compared to PATHWAY HER-2 (clone CB11) Primary Antibody on an independent sample set and found to provide acceptably concordant results. The actual correlation of PATHWAY anti-HER-2/neu (4B5) to clinical outcome has not been established. en PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY anti-HER2 (4B5) antibody) is a rabbit monoclonal antibody intended for laboratory use for the semi-quantitative detection of HER2 antigen by immunohistochemistry (IHC) in sections of formalin-fixed, paraffin- embedded breast carcinoma and biliary tract cancer (gallbladder adenocarcinoma, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma) tissue using the ultraView Universal DAB Detection Kit on a BenchMark ULTRA instrument. The IHC device is indicated for identifying patients who are eligible for treatment with the following therapies in accordance with the approved therapeutic labeling: Indications for use Status Therapy Breast carcinoma IHC 3+ or IHC 2+/ISH amplified Herceptin® Breast carcinoma IHC 3+ or IHC 2+/ISH amplified KADCYLA® Breast carcinoma IHC 0 with membrane staining, IHC 1+ or IHC 2+/ISH non-amplified ENHERTU® Biliary tract cancer IHC 3+ ZIIHERA® Test results 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. en PATHWAY anti-HER2 (4B5) antibody is a rabbit monoclonal antibody, which binds to HER2 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. Each step is incubated for a precise time and temperature. At the end of each incubation step, the instrument washes the sections to stop the reaction and to remove unbound material that would hinder the desired reaction in subsequent steps. The instrument applies Liquid Coverslip, which minimizes evaporation of the aqueous reagents from the specimen slide.Clinical cases should be evaluated within the context of the performance of appropriate controls. The inclusion of a positive tissue control fixed and processed in the same manner as the patient specimen is recommended (for example, a weakly positive breast carcinoma). In addition to staining with PATHWAY anti-HER2 (4B5) 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 membrane staining of the tumor cells. These components should be negative when stained with CONFIRM Negative Control Rabbit Ig. In addition, it is recommended that a negative tissue control (for example, a HER2 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 PATHWAY anti-HER2 (4B5) antibody to ensure that the antigen enhancement and other pretreatment procedures did not create false positive staining. The use of VENTANA pre-diluted PATHWAY anti-HER2 (4B5) antibody and ready-to-use iVIEW DAB and ultraView Universal DAB Detection Kits, in combination with a BenchMark IHC/ISH instrument, reduces the possibility of human error and inherent variability resulting from individual reagent dilution, manual pipetting, and manual reagent application. en PATHWAY anti-HER2 (4B5) antibody is a rabbit monoclonal antibody, which binds to HER2 in formalin-fixed, paraffin-embedded (FFPE) tissue sections. The specific antibody is located by a cocktail of enzyme-labeled secondary antibodies that recognize rabbit immunoglobulins followed by the addition of a secondary antibody-HRP conjugate (ultra View Universal DAB Detection Kit). The specific antibody-enzyme complex is then visualized with a precipitating enzyme reaction product. Each step is incubated for a precise time and temperature. At the end of each incubation step, the BenchMark ULTRA instrument washes the sections to stop the reaction and to remove unbound material that would hinder the desired reaction in subsequent steps. It also applies Liquid Coverslip, which minimizes evaporation of the aqueous reagents from the specimen slide. Clinical cases should be evaluated within the context of the performance of appropriate controls. 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) is recommended. In addition to staining with PATHWAY anti-HER2 (4B5) 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 membrane staining of the tumor cells. These components should be negative when stained with CONFIRM Negative Control Rabbit Ig. In addition, it is recommended that a negative tissue control (for example, a HER2 negative breast carcinoma, or non-staining components of the same tissue used for the positive tissue control) be included for every batch of samples processed and run on a BenchMark ULTRA instrument. This negative tissue control should be stained with PATHWAY anti-HER2 (4B5) antibody to ensure that the antigen enhancement and other pretreatment procedures did not create false positive staining. The use of pre-diluted PATHWAY anti-HER2 (4B5) antibody and ready-to-use ultra View Universal DAB Detection Kit, in combination with a BenchMark ULTRA instrument, reduces the possibility of human error and inherent variability resulting from individual reagent dilution, manual pipetting, and manual reagent application. en

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PATHWAY^® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

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