Product Listing

Breast cancer IHC/ISH portfolio

breast cancer



Deliver diagnostic confidence with the Roche portfolio of diagnostic solutions

Breast cancer remains a significant scientific, clinical and societal challenge claiming more than 600,000 lives worldwide each year. Each cancer diagnosis is as distinct as the individual it affects. Understanding the diversity in breast cancer allows for patient stratification and more personalized treatment pathways. Biomarkers provide objective observations of tumor profiles, including prognostic and predictive information leading to more guided measures of patient management.

Roche is committed to contributing to improved outcomes in breast cancer by bringing you the most comprehensive panel of breast cancer diagnostic assays so that you can deliver personalized, confident results for each patient.

Clinical Utility

The Roche breast cancer diagnostic assays provide you with a complete portfolio of the critical markers you need to deliver the right test for each patient in the shortest possible time.

Analytical Performance

Specific and sensitive rabbit monoclonal antibodies, best-in-class probes, and powerful detection systems help you diagnose precisely and confidently.

Testing Efficiency

Our comprehensive breast cancer workflow solution delivers fully automated assays on market-leading platforms, with digital pathology and workflow solutions that free resources, reduce labor costs, and reduce time to result.

Featured Assays

HER2 4B5
PATHWAY HER2 (4B5) Rabbit Monoclonal Primary Antibody

The use of pre-diluted PATHWAY HER2 (4B5),14 in combination with the fully automated VENTANA BenchMark IHC/ISH slide staining instrument, standardizes all IHC processes from baking through staining, and reduces the possibility of human error. It also minimized inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods. 

The PATHWAY HER2 (4B5) Primary Antibody empowers you to: 
  • Achieve consistently high proficiency assessment scores with HER2 (4B5) antibody, compared to other clones3
  • Employ the most widely adopted and reliable HER2-IHC primary antibody3
  • Demonstrate high concordance with HER2 FISH4,5
VENTANA HER2 Dual ISH DNA Probe Cocktail Assay

The new VENTANA HER2 Dual ISH assay is a fully automated, ready-to-use brightfield solution for determining HER2 gene amplification. This assay helps identify breast cancer patients eligible for treatment with HERCEPTIN® (trastuzimab)

  • FDA approved
  • New detection chemistry with improved anti-hapten technology results in unparalleled signal intensity without increased background1
  • Improved performance in turn-around time and first pass rates2
  • Convenient brightfield detection technology to perform a comprehensive analysis of tissue on the slide and evaluate HER2 gene status with morphological context
CONFIRM ER (SP1) Rabbit Monoclonal Primary Antibody

CONFIRM ER (SP1) is an FDA cleared antibody indicated as an aid in patient management, prognosis, and the prediction of therapy outcomes in breast cancer.6

  • ER (SP1) is a significant predictor of disease-specific survival.7,8
  • Rapid and consistent results delivered through fully automated platforms and digital pathology solutions
CONFIRM PR (1E2) Rabbit Monoclonal Primary Antibody

CONFIRM PR (1E2) is an FDA cleared antibody indicated as an aid in patient management, prognosis, and the prediction of therapy outcomes in breast cancer.9

  • Provides significant value as a prognostic factor and response prediction of hormone therapy, even in ER negative patients.10
  • Rapid and consistent results through fully automated platforms and digital pathology solutions
CONFIRM anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody
  • Aids in assessing the proliferative activity of normal and neoplastic cells
  • Rabbit monoclonal antibody demonstrates increased sensitivity and strong specificity compared with mouse monoclonal antibodies
  • Intense nuclear staining and no adipose (K2) or cell membrane staining can help deliver a confident assessment of tumor aggressiveness



  1. Ventana Product Document Library. Interpretation Guide for VENTANA HER2 Dual ISH DNA Probe Cocktail assay; staining for breast carcinoma.
  2. Ventana Product Document Library. Package Insert, VENTANA HER2 Dual ISH DNA Probe Cocktail
  3. Based on 5 years of data from a leading external quality assessment scheme. Retrieved from
  4. 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 fluorescence in situ hybridization (FISH). Virchows Archiv. 2009; 454(3): 241–248.
  5. 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.
  6. CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody [package insert]. Tucson, AZ: VENTANA Medical Systems, Inc.; 2008.
  7. Welsh A, et al. Quantitative Analysis of Estrogen Receptor Expression Shows SP1 Antibody Is More Sensitive Than 1D5. Appl Immunohistochem Mol Morphol. 2013;21(2):139-147
  8. Yamamoto-Ibusuki M, Yamamoto Y, Yamamoto S, et al. Comparison of prognostic values between combined immunohistochemical score of estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2, Ki-67 and the corresponding gene expression score in breast cancer. Mod Patholo 2013: 26):79–86.
  9. 8 CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody [package insert]. Tucson, AZ: VENTANA Medical Systems, Inc.; 2008.
  10. Liu, S, Cchia SK, Mehl, E, et al. Breast Cancer Res Treat. Progesterone receptor is a significant factor associated with clinical outcomes and effect of adjuvant tamoxifen therapy in breast cancer patients. 2010;119:53-61.


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