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VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx

CE-IVD
IVD For in vitro diagnostic use.
HER2-4B5-cdx-stain

Leading the way in HER2 testing

The use of pre-diluted VENTANA HER2 (4B5) Rabbit Monoclonal Antibody RxDx1, 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

Elevating hope for lower expression

Building on the same proven technology trusted for consistently achieving higher overall proficiency scores compared to other clones2, Roche’s widely adopted assay* is now approved to identify HER2-low breast cancer patients, helping to match even more women with highly effective, personalised therapies. It is the first and only test approved to identify breast cancer patients with HER2-low status who may be eligible for targeted treatment with ENHERTU.1

* PATHWAY/VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody products

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.2

* Based on data for PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody products.

EQA Chart

Criteria for intensity and pattern of cell membrane staining with VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx

For breast carcinoma specimens when using the staining procedure for all HER2 assessment including potential HER2-low assessment

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 > 10% of the cancer cells** 1+ HER2-low expression ENHERTU (trastuzumab deruxtecan)
Weak to moderate complete staining of the membrane in > 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)
PERJETA (pertuzumab)
Intense complete staining of the membrane in > 10% of the cancer cells 3+ HER2-positive/overexpression
Criteria for intensity and pattern of cell membrane staining with VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx when using the staining procedure for all HER2 assessment including potential HER2-low assessment in breast specimens

For breast carcinoma specimens when using the alternative staining procedure intended for use in assessing HER2-positivity and not in assessing HER2-low expression

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 > 10% of the cancer cells 1+ HER2-negative
Weak to moderate complete staining of the membrane in > 10% of the cancer cells 2+***
Reflex test: HER2 non-amplified

HER2-negative

2+***
Reflex test: HER2 amplified
HER2-positive/overexpression HERCEPTIN (trastuzumab)
KADCYLA (trastuzumab emtansine)
PERJETA (pertuzumab)
Intense complete staining of the membrane in > 10% of the cancer cells 3+ HER2-positive/overexpression
Criteria for intensity and pattern of cell membrane staining with VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx when using the alternative staining procedure intended for use in assessing HER2-positivity (defined as protein overexpression, IHC score 3+ or 2+ (with a confirmed HER2 amplified status)) and not in assessing HER2-low expression (defined as IHC score 1+ or 2+ (with a confirmed HER2 non-amplified status))

For gastric carcinoma specimens

Staining pattern - resection specimen HER2 (4B5) score (report to treating physician) Recommended reporting status Therapy*
No reactivity or membranous reactivity in < 10% of tumour cells No reactivity or membranous reactivity in any tumour cell 0 Negative
Faint/barely perceptible membranous reactivity in ≥ 10% of tumour cells; cells are reactive only in part of their membrane Tumour cell cluster† with a faint/barely perceptible membranous reactivity irrespective of percentage of tumour cells stained 1+ Negative
Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells Tumour cell cluster† with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained

2+

Equivocal††
Strong complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells Tumour cell cluster† with a strong complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained 3+ Positive
Criteria for intensity and pattern of cell membrane staining with VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx in gastric carcinoma

* Refers to HER2-targeted therapies

** 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

† ≥ 5 cohesive cells

†† Recommend reflex to ISH

References

  1. VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx Package Insert, 2023.
  2. NordiQC Assessments. https://www.nordiqc.org/epitope.php; accessed November 2023
  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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