For in vitro diagnostic use. Membrane Others HER-2 neu 4B5 PATHWAY IVD Breast Carcinoma PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody RTD001084 Rabbit 4B5 05 278 368 001 5 278 368 001 05278368001 5278368001 05278368001 PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONO PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody 04015630972197 Reagents, kits 790-2991 50 tests Not Available true 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 IHC/ISH instrument. It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (trastuzumab) or KADCYLA® (ado-trastuzumab emtansine) treatment is being considered.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.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. en PATHWAY anti-HER2 (4B5) antibody is a rabbit monoclonal antibody, which binds to HER2 in formalin-fixed, paraffin-embedded (FFPE) tissue sections. The specific antibody can be localized by either a biotin conjugated secondary antibody formulation that recognizes rabbit immunoglobulins followed by the addition of a streptavidin-horseradish peroxidase (HRP) conjugate (iVIEW DAB Detection Kit) or a secondary antibody-HRP conjugate (ultraView Universal DAB Detection Kit). The specific antibody-enzyme complex is then visualized with a precipitating enzyme reaction product. Each step is incubated for a precise time and temperature. At the end of each incubation step, the instrument washes the sections to stop the reaction and to remove unbound material that would hinder the desired reaction in subsequent steps. The instrument applies Liquid Coverslip, which minimizes evaporation of the aqueous reagents from the specimen slide.Clinical cases should be evaluated within the context of the performance of appropriate controls. The inclusion of a positive tissue control fixed and processed in the same manner as the patient specimen is recommended (for example, a weakly positive breast carcinoma). In addition to staining with PATHWAY anti-HER2 (4B5) antibody, a second slide should be stained with CONFIRM Negative Control Rabbit Ig. For the test to be considered valid, the positive control tissue should exhibit membrane staining of the tumor cells. These components should be negative when stained with CONFIRM Negative Control Rabbit Ig. In addition, it is recommended that a negative tissue control (for example, a HER2 negative breast carcinoma) be included for every batch of samples processed and run on the BenchMark IHC/ISH instrument. This negative tissue control should be stained with PATHWAY anti-HER2 (4B5) antibody to ensure that the antigen enhancement and other pretreatment procedures did not create false positive staining. The use of VENTANA pre-diluted PATHWAY anti-HER2 (4B5) antibody and ready-to-use iVIEW DAB and ultraView Universal DAB Detection Kits, in combination with a BenchMark IHC/ISH instrument, reduces the possibility of human error and inherent variability resulting from individual reagent dilution, manual pipetting, and manual reagent application. en

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

IVD

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.¹It 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 FISH^3,4

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

US IVD

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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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	ENHERTU (fam-trastuzumab deruxtecan-nxki)
	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	Herceptin (trastuzumab), KADCYLA (trastuzumab emtansine)

* 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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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

CE IVD

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

View Full Table

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

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

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