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VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody (CE IVD)

Roche VENTANA HER2 4B5 breast cancer IHC stain

Leading the way in HER2 testing

The use of pre-diluted VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody1 (VENTANA HER2 (4B5) Antibody), 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 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.

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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 **

* Data 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

Intended use

VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is intended for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic breast and gastric tissue on a BenchMark IHC/ISH instrument.

This product is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin® (trastuzumab) treatment is considered and for breast cancer patients for whom KADCYLA® (ado-trastuzumab emtansine) or PERJETA® (pertuzumab) treatments are 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.

Criteria for Intensity and Pattern of Cell Membrane Staining with VENTANA HER2 (4B5) antibody in Breast Carcinoma:

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Criteria for Intensity and Pattern of Cell Membrane Staining with VENTANA HER2 (4B5) antibody in Breast Carcinoma:

Criteria for Intensity and Pattern of Cell Membrane Staining with VENTANA HER2 (4B5) antibody in Breast Carcinoma:
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, > 10% of cancer cells 2+

Equivocal*
Intense complete staining of the membrane, > 10% of cancer cells 3+ Positive
* Recommend reflex to ISH

Criteria for Intensity and Pattern of Cell Membrane Staining with VENTANA HER2 (4B5) antibody in Gastric Carcinoma:

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Criteria for Intensity and Pattern of Cell Membrane Staining with VENTANA HER2 (4B5) antibody in Gastric Carcinoma:

Staining Pattern - Resection Specimen

 Score (Report to requesting physician) HER2 Staining Assessment
No reactivity or membranous reactivity in < 10% of tumor cells 0 Negative
Faint/barely perceptible membranous reactivity in ≥ 10% of tumor cells; cells are reactive only in part of their membrane 1+ Negative
Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10% of tumor cells 2+ Equivocal**
Strong complete, basolateral or lateral membranous reactivity in ≥ 10% of tumor cells 3+ Positive
* ≥ 5 cohesive cells ** Recommend reflex to ISH
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VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody

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      References

      1. VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody Package Insert, 2019.
      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.
         

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