Product Listing

Breast cancer IHC/ISH portfolio

Deliver diagnostic confidence with the Roche breast cancer IHC portfolio

A leader in breast cancer diagnostics, Roche Diagnostics offers numerous cancer diagnostic assays that enable pathology labs to deliver accurate results with confidence. We provide a robust menu of breast cancer diagnostic tools. Our portfolio of products delivers the high sensitivity and specificity you need from your assays.


Immunohistochemistry (IHC) analysis and in situ hybridization (ISH) analysis

Experts predict over 500,000 deaths annually due to breast cancer, making it a leading cause of death in women. In developed countries breast cancer related mortality has declined, in part due to therapeutic advances and evolution of biomarkers. For example, Immunohistochemistry (IHC) analysis and in situ hybridization (ISH) analysis provide important information related to tumor biology, help profile types of breast cancer and may improve treatment decisions.


Clinical benefit

With proven accuracy, VENTANA breast cancer diagnostic assays help you identify patients other assays can miss – so you can deliver the right test, with clinical confidence in the shortest possible time.


Analytical advantage

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 results.

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 clones15
  • Employ the most widely adopted and reliable HER2-IHC primary antibody15
  • Demonstrate high concordance with HER2 FISH16,17
INFORM HER2 Dual ISH DNA Probe Cocktail assay
  • FDA-approved as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.
  • Convenient brightfield detection technology to perform a comprehensive analysis of tissue on the slide, and evaluate HER2 gene status with morphological context
  • Identify intratumoral heterogeneity
  • Greatly reduced time to result with full automation1,2
  • Run the test in-house instead of sending it out
CONFIRM ER (SP1) Rabbit Monoclonal Primary Antibody
  • 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
  • FDA cleared antibody
  • Indicated as an aid in patient management, prognosis, and the prediction of therapy outcomes in breast cancer.9
  • Provide 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
VENTANA PD-L1 (SP142) Assay
Identify Triple-negative breast (TNBC)
cancer patients  eligible for TECENTRIQ®

Using the right test to determine PD-L1 status for immunotherapy options is important. The VENTANA PD-L1 (SP142) Assay gives you the confidence to reliably identify triple-negative breast cancer (TNBC) patients eligible for TECENTRIQ.®11,12

The novel VENTANA PD-L1 (SP142) Assay is easy to score and the first with FDA-approval to evaluate breast cancer patients for PD-L1 expression using immune cell staining and scoring within the tumor microenvironment. The assay provides you with information that multidisciplinary teams need to guide immunotherapy decisions in TNBC. The VENTANA PD-L1 (SP142) Assay:

  • FDA approved to predict TNBC patients eligible for treatment with TECENTRIQ™



  1. Loftin IR, et al. The new FDA-approved INFORM HER2 Dual ISH assay is concordant to FISH and reproducible in determining HER2 gene status in invasive breast carcinoma. Poster presented at the ASCO Breast Cancer Symposium; 2011; September 8-10: San Francisco, California, USA.
  2. ECONOMICAL AND ORGANIZATIONAL IMPACT OF ADOPTING DIFFERENT IN SITU HYBRIDIZATION TECHNOLOGIES TO ASSESS HER2 GENE AMPLIFICATION IN BREAST CANCER Paolini D1, Rossoni R1, Guardione D1, Arena V2 1Roche Diagnostics S.p.A., Monza, Italy, 2Policlinico Universitario, Rome, Italy, ISPOR 18th Annual European Congress Research Abstracts
  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.
  11. TECENTRIQ Prescribing Information
  12. Ventana Product Document Library. Package Insert. VENTANA PD-L1 (SP142) Assay.


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