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PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody (FDA approved)

Roche Pathway HER2 4B5 assay slide and therapy image

Leading the way in HER2 testing

The use of pre-diluted PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody1 (PATHWAY HER2 (4B5)), in combination with the fully automated BenchMark IHC/ISH slide staining instrument, standardizes all IHC processes from baking through staining, and reduces the possibility of human error.1 It also minimizes inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods.

The PATHWAY anti-HER2/neu (4B5) clone* empowers you to:

• Achieve 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-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody

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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 **
 

* Refers to PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Antibody.
**Based on data from a leading external quality assessment scheme.2

Chart showing the consistent performance of Roche 4b5 PATHWAY RTU compared to Daka A0485, Dako Herceptest SK001, and Leica Oracle.

Related links

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    References
    1. PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody Package Insert.
    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 Her2/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.
       
    Intended use

    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 normal and neoplastic breast tissue using the ultraView Universal DAB Detection Kit on a BenchMark ULTRA instrument.

    This IHC device is indicated for identifying breast cancer patients who are eligible for treatment with Herceptin® (IHC 3+ or IHC 2+/ISH amplified), KADCYLA® (IHC 3+ or IHC 2+/ISH amplified) or ENHERTU® (IHC 1+ or IHC 2+/ISH non-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.

    Indication for use: breast cancer

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    Indication for use: breast cancer

    Table 1. PATHWAY anti-HER2 (4B5) Antibody Companion Diagnostic Indications.
    Breast Cancer  Staining Pattern Score Recommended Reporting Status Clinical Application

    No membrane staining is observed

    OR

    Faint, partial staining of the membrane in 10% or LESS of the cancer cells*

    		 0 HER2 Negative None
    Faint, partial staining of the membrane in greater than 10% of the cancer cells* 1+ HER2-low expression

    ENHERTU®

    (fam-trastuzumab deruxtecan-nxki)
    Weak to moderate complete staining of the membrane in greater than 10% of the cancer cells Positve Weak to moderate complete staining of the membrane in greater than 10% of the cancer cells Positve

    2+*

    Reflex test: HER2 Non-Amplified

    		 HER2-low expression

    2+*

    Reflex test: HER2 Amplified

    		 HER2 Positive/overexpression

    Herceptin® (trastuzumab),

    KADCYLA® (trastuzumab emtansine)
    Intense complete staining of the membrane in greater than 10% of the cancer cells 3+ HER2 Positive/overexpression
    *Recommend re-reading by a second pathologist for cases with “faint, partial staining of the membrane” and %TC near the threshold of 10%, when the range of %TC is between 5%-25%
    **Recommend reflex test to assess gene amplification per ASCO/CAP guidance
     
    View product details for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody
     

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