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.
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 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® (adotrastuzumab emtansine) treatment is being considered.

Table 1. PATHWAY anti-HER2 (4B5) Antibody Companion Diagnostic Indications.

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Table 1. PATHWAY anti-HER2 (4B5) Antibody Companion Diagnostic Indications.

Table 1. PATHWAY anti-HER2 (4B5) Antibody Companion Diagnostic Indications.

Indication for Use

Score

Staining Pattern

Clinical Application

 

 

 

 

 

 

 

Breast Cancer

0

No membrane staining is observed

Or

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

None
1+ Faint, partial staining of the membrane in greater than 10% of the cancer cells None

2+*

Reflex test: HER2 Non-Amplified

 

Weak to moderate complete staining of the membrane in greater than 10% of the cancer cells

None

2+*

Reflex test: HER2 Amplified

Herceptin® (trastuzumab),

KADCYLA® (trastuzumab emtansine)

3+ Intense complete staining of the membrane in greater than 10% of the cancer cells
* Equivocal: Recommend reflex test according to ASCO/CAP guidance.
 
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