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

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

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

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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 and VENTANA products.

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

US IVD

Intended use

The PATHWAY anti-HER2/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 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.

Scoring Conventions for the Interpretation of PATHWAY anti-HER2 (485) 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 with PATHWAY anti-HER2 (4B5) antibody.

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

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Table 1. PATHWAY anti-HER2 (4B5) Antibody Companion Diagnostic Indications.
STAINING PATTERN	HER2 (4B5) Score (Report to treating physician)	Recommended Reporting Status	Therapy
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*	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

CE IVD

Intended use

The PATHWAY anti-HER2/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^® 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 anti-HER2/neu (4B5). PATHWAY anti-HER2/neu (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 anti-HER2/neu (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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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