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VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx

VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx

Leading the way in HER2 testing

The use of ready-to-use VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx1 (VENTANA HER2 (4B5) Antibody), in combination with the fully automated BenchMark IHC/ISH slide staining instrument, standardises all IHC processes from baking through staining, and reduces the possibility of human error. It also minimises inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods.

The Roche HER2 (4B5) clone* empowers you to:

  • Achieve consistently high proficiency assessment scores compared to other clones2
  • Employ the most widely adopted and reliable HER2-IHC primary antibody2
  • Demonstrate high concordance with HER2 FISH3,4

*Refers to the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody and VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx products.

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Consistent performance and superior quality

The Roche HER2 (4B5) clone* has shown the most consistent performance and superior quality when compared to other on-market HER2 clones **

* Data refers to PATHWAY and VENTANA products.

**Based on data from a leading external quality assessment scheme. Retrieved from http://www.nordiqc.org/epitope.php

VENTANA PATHWAY HER2 4B5 breast cancer stain diagram

Intended use

VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx is intended for the semi-quantitative detection of HER2 antigen by immunohistochemistry (IHC) in sections of formalin-fixed, paraffin-embedded breast and gastric tissue stained on a BenchMark IHC/ISH instrument.

This IHC device is indicated for identifying breast cancer patients who are eligible for treatment with trastuzumab (IHC 3+ or IHC 2+/ISH amplified), pertuzumab (IHC 3+ or IHC 2+/ISH amplified), trastuzumab emtansine (IHC 3+ or IHC 2+/ISH amplified), or famtrastuzumab deruxtecan-nxki (IHC 1+ or IHC 2+/ISH non-amplified). 

Additionally, this IHC device is an aid in the assessment of gastric cancer patients for whom trastuzumab treatment is being considered (IHC 3+ or IHC 2+/ISH amplified). 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.

Criteria for Intensity and Pattern of Cell Membrane Staining with VENTANA HER2 (4B5) antibody in Breast Carcinoma:

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Criteria for Intensity and Pattern of Cell Membrane Staining with VENTANA HER2 (4B5) antibody in Breast Carcinoma:

Criteria for Intensity and Pattern of Cell Membrane Staining with VENTANA HER2 (4B5) antibody in Breast Carcinoma:
Staining Pattern Score
(Report to Treating Physician)		 HER2 Staining Assessment
No membrane staining is observed 0 Negative
Faint, partial staining of the membrane in any proportion of the cancer cells 1+ Negative
Weak complete staining of the membrane, > 10% of cancer cells 2+

Equivocal*
Intense complete staining of the membrane, > 10% of cancer cells 3+ Positive
* Recommend reflex to ISH

Criteria for Intensity and Pattern of Cell Membrane Staining with VENTANA HER2 (4B5) antibody in Gastric Carcinoma:

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Criteria for Intensity and Pattern of Cell Membrane Staining with VENTANA HER2 (4B5) antibody in Gastric Carcinoma:

Staining Pattern - Resection Specimen

 Score (Report to requesting physician) HER2 Staining Assessment
No reactivity or membranous reactivity in < 10% of tumour cells 0 Negative
Faint/barely perceptible membranous reactivity in ≥ 10% of tumour cells; cells are reactive only in part of their membrane 1+ Negative
Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells 2+ Equivocal**
Strong complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells 3+ Positive
* ≥ 5 cohesive cells ** Recommend reflex to ISH
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VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody

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    BENCHMARK, VENTANA and PATHWAY are tradmarks of Roche.

    All other product names and trademarks are the property of their respective owners

    THESE PRODUCTS ARE NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC.

    ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE.

    References

    1. VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody Package Insert, 2019.
    2. NordiQC Assessments. http://www.nordiqc.org/epitopes.htm Accessed September 19, 2016.
    3. Mayr D, et al. Comprehensive immunohistochemical analysis of Her-2/neu oncoprotein overexpression in breast cancer: HercepTest™ (Dako) for manual testing and Her-2/neuTest 4B5 (VENTANA) for VENTANA BenchMark automatic staining system with correlation to results of BenchMark automatic staining system with correlation to results of fluorescence in situ hybridization (FISH). Virchows Archiv. 2009; 454(3):241–248.
    4. Brügmann A, Lelkaitis G, Nielsen S, et al. Testing HER2 in breast cancer: a comparative study on BRISH, FISH, and IHC. Appl Immunohistochem Mol Morphol. 2011;19(3):203-211.