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:
*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.
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 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.
(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+||
|Intense complete staining of the membrane, > 10% of cancer cells||3+||Positive|
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|
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