PATHWAY anti-HER-2/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-HER-2/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.It also minimizes 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 with the Roche HER2 (4B5) clone, 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 anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody products.

 

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 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

  1. PATHWAY anti-HER-2/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 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.
     
Intended use

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 XT or BenchMark ULTRA instrument. It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (trastuzumab) or KADCYLA®

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.

Criteria for Intensity and Pattern of Cell Membrane Staining with PATHWAY HER2 (4B5) Antibody:

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Criteria for Intensity and Pattern of Cell Membrane Staining with PATHWAY HER2 (4B5) Antibody:

Criteria for Intensity and Pattern of Cell Membrane Staining with PATHWAY HER2 (4B5) Antibody:

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, greater than 10% of cancer cells 2+

Weakly Positive*

Intense complete staining of the membrane, greater than 10% of cancer cells 3+ Positive
* Recommend reflex to ISH
View product details for the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

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