Breast cancer IHC/ISH portfolio

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.

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 FISH^4,5

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

VENTANA PD-L1 (SP142) Assay

Using the right test to determine PD-L1 status for immunotherapy options is important. The FDA approved 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.

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

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