Breast cancer IHC/ISH portfolio

Deliver diagnostic confidence with the Roche breast cancer IHC/ISH 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

CONFIRM ER (SP1) Rabbit Monoclonal Primary 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

VENTANA PD-L1 (SP142) Assay

First and only CE-IVD marked test clinically proven to identify triple-negative breast cancer patients eligible for and most likely to benefit from TECENTRIQ
Designed to enhance visual contrast of immune cell staining within the tumor microenvironment
Designed to enhance visual contrast of immune cell staining within the tumor microenvironment

First scoring algorithm using PD-L1 staining in tumor-infiltrating immune cells

VENTANA HER2 Dual ISH DNA Probe Cocktail assay

CE IVD approved test
Increased performance with oligo probes and new detection kits
Easily interpreted using brightfield microscopy
Robust and highly reproducible between laboratories and pathologists
Highly concordant with FISH

INFORM HER2 Dual ISH DNA Probe Cocktail assay

FDA-approved test
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 results with full automation^1,2
Run the test in-house instead of sending it out

PATHWAY HER2 (4B5) Rabbit Monoclonal Primary Antibody

FDA-approved antibody
Higher overall proficiency assessment scores with HER2 (4B5) than with any other clones³
Widely adopted and reliable HER2 IHC primary antibody⁷
High concordance with HER2 ISH^4,5

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

References

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.
Paolini D, Rossoni R, Guardione D, Vrena V. Economical and organizational impact of adopting different in situ hybridization technologies to assess HER2 gene amplification in breast cancer. Poster presented at the 18th Annual European
Based on 5 years of data from a leading external quality assessment scheme. Retrieved from http://www.nordiqc.org/epitopes.htm
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.
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.
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody [package insert]. Tucson, AZ: VENTANA Medical Systems, Inc.; 2008.
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
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.
8 CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody [package insert]. Tucson, AZ: VENTANA Medical Systems, Inc.; 2008.
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.