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

IVD For in vitro diagnostic use.
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 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

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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 the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and VENTANA® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody products.

**Based on data from a leading external quality assessment scheme.2

VENTANA PATHWAY HER2 4B5 breast cancer stain diagram

Intended use1

The PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) is intended for laboratory use for the semi-quantitative detection of HER2 antigen 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 patients who are eligible for treatment with the following therapies in accordance with the approved therapeutic labeling:

  • Breast carcinoma: 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)
  • Biliary tract carcinoma (BTC): ZIIHERA® (IHC 3+)

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.

Scoring Conventions for the Interpretation of PATHWAY HER2 (4B5) Antibody

Below is a quick reference chart for staining criteria. Refer to Interpretation Guide for PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody for a more detailed description with photographs of staining.

Scoring Criteria for Intensity and Pattern of Cell Membrane Staining with PATHWAY HER2 (4B5) Antibody in Breast Cancer

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Scoring Criteria for Intensity and Pattern of Cell Membrane Staining with PATHWAY HER2 (4B5) Antibody in Breast Cancer

Table 1. PATHWAY HER2 (4B5) Antibody Companion Diagnostic Indications.
Staining Pattern Score (report to treating physician) Recommended Reporting Status Therapy
No membrane staining is observed
OR
Faint, partial staining of the membrane in10% 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* 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

Scoring Criteria for Intensity and Pattern of Cell Membrane Staining with PATHWAY anti-HER2 (4B5) Antibody in Biliary Tract Cancer

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Scoring Criteria for Intensity and Pattern of Cell Membrane Staining with PATHWAY anti-HER2 (4B5) Antibody in Biliary Tract Cancer

Table 2. Scoring Criteria for Intensity and Pattern of Cell Membrane Staining with PATHWAY HER2 (4B5) Antibody in Biliary Tract Cancer
Staining Pattern (resection specimen) Staining Pattern (biopsy specimen*) Score (report to requesting physician) Recommended Reporting Status Therapy
No reactivity or membranous reactivity in <10% of tumor cells No reactivity membranous reactivity in any tumor cell 0 HER2 negative

 

Treatment

ineligible
Faint/barely perceptible membranous reactivity in ≥10% of tumor cells; cells are reactive only in part of their membrane Tumor cell cluster** with a faint/barely perceptible membranous reactivity irrespective of percentage of tumor cells stained 1+
Weak to moderate complete, basolateral or lateral membranous reactivity in ≥10% of tumor cells Tumor cell cluster with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumor cells stained

2+***

 

 

 
Strong complete, basolateral or lateral membranous reactivity in ≥10% of tumor cells Tumor cell cluster with a strong, complete basolateral or lateral embranousreactivity irrespective of percentage of tumor cells stained 3+ HER2 positive ZIIHERA (zanidatamab)
* Biopsy specimens include endoscopic, pinch, and needle core
** ≥5 cohesive cells
*** Recommend reflex test to assess gene amplification

Intended use5

The PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) is 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® are being considered.

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 HER2 (4B5). PATHWAY HER2 (4B5) was compared to PATHWAY HER2 (clone CB11) Primary Antibody on an independent sample set and found to provide acceptably concordant results. The actual correlation of PATHWAY HER2 (4B5) to clinical outcome has not been established.

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 PATHWAY HER2 (4B5) Antibody

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

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

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      References

      1. PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody Package Insert (D197603), 2024.
      2. NordiQC Assessments. https://www.nordiqc.org/epitope.php?id=11. Accessed October 1, 2024.
      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.
      5. PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody Package Insert (14427EN Rev H), 2022.
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