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Breast cancer IHC/ISH portfolio

Roche Diagnostics
Published on February 25, 2024 | 5 min read
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Deliver diagnostic confidence with the Roche breast cancer IHC/ISH portfolio

As 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) and in situ hybridization (ISH)

Experts predict over 680,000 deaths annually due to breast cancer, making it a leading cause of death in women.1 In developed countries breast cancer-related mortality has declined, in part due to therapeutic advances and evolution of biomarkers.2,3 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.4

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 time possible.

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 up resources, reduce labor costs and reduce time to results.

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Breast cancer diagnostics

Roche offers a comprehensive portfolio of diagnostic solutions from initial detection to ongoing management, empowering informed and precise breast cancer care.
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Featured products and solutions

VENTANA PD-L1 (SP142) Assay is intended for the immunohistochemical assessment of the programmed death-ligand 1 (PD-L1) protein in tumor cells and tumor infiltrating immune cells in formalin-fixed, paraffin-embedded (FFPE) tumor tissue stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a VENTANA BenchMark IHC/ISH instrument.
The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is a fully automated, ready-to-use brightfield solution for determining HER2 gene status.
PATHWAY HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, one of over 250 optimized pre-diluted reagents for use on the BenchMark IHC/ISH automated slide staining instruments by Roche Diagnostics.
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    Contributors

    Roche-Hochhaus - Ansicht Südwest - Burckhardt Partner AG - 2011 - Rotkreuz

    Roche Diagnostics

    Roche Diagnostics is a division of Roche, developing and integrating diagnostic solutions that address today’s healthcare challenges while anticipating tomorrow’s needs. In more than 100 countries, we provide one of the industry’s most comprehensive in vitro diagnostics portfolios spanning molecular diagnostics, clinical chemistry and immunoassays, tissue diagnostics, Point of Care testing, patient self-testing, next-generation sequencing, laboratory automation and IT, as well as digital health and decision-support solutions.

    Our articles are authored by Roche Diagnostics subject matter experts, drawing on collective expertise across multiple disciplines to provide reliable insights for healthcare professionals worldwide.

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    Contact us

    Do you have questions about our products or services? We’re here to help. Contact a Roche representative in your region.

    Contact us

    References

    1. WHO Globocan 2020 Breast Cancer Fact Sheet. https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf
    2. Berry DA, Cronin KA, Plevritis SK, et al. Effect of screening and adjuvant therapy on mortality from breast cancer. N Engl J Med. 2005;353:1784‐1792.
    3. Munoz D, Near AM, van Ravesteyn NT, et al. Effects of screening and systemic adjuvant therapy on ER‐specific US breast cancer mortality. J Natl Cancer Inst. 2014;106:dju289.
    4. Godoy-Ortiz, A. et al. Deciphering HER2 Breast Cancer Disease: Biological and Clinical Implications. Front. Oncol. 2019;9:1124
    5. CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody package insert, 2013.
    6. 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.
    7. Yamamoto-Ibusuki M. et al. Comparison of prognostic values between combined immunohistochemical score of estrogen receptor, progesterone receptor, human epidermal growth factor receptor Ki-67 and the corresponding gene expression score in breast cancer. Mod Patholo 2013:26:79-86.
    8. VENTANA HER2 Dual ISH DNA Probe Cocktail Assay package insert, 2020.
    9. Lim, SJ. et al. Validation and workflow optimization of human epidermal growth factor receptor 2 testing using INFORM HER2 dual-color in situ hybridization. Human Pathology. 2013; 44, 2590–2596.
    10. Ruschoff, J. et al. ISH-based HER2 diagnostics. Pathologe. 2020;(6):606-613.
    11. Based on 5 years of data from a leading external quality assessment scheme. B30 2020 HER2 IHC assessment run. Retrieved from http/www.nordiqc.org/epitopes.htm.
    12. Mayr D. et al. Comprehensive immunohistochemical analysis of Her-2/neu oncoprotein overexpression in breast cancer: HercepTest (Dako) for manual testing and Her-2/neu Test 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.
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    14. CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody package insert, 2012.
    15. Liu, S. Chia SK. Mehl, E. et al. Progesterone receptor is a significant factor associated with clinical outcomes and effect of adjuvant tamoxifen therapy in breast cancer patients. Breast Cancer Res Treat 2010:119:53-61.
    16. Keng PC, Siemann DW. Measurement of proliferation activities in human tumor models: a comparison of flow cytometric methods. Radiatn Oncol Investig. 1998: 6(3): 120-127.
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    18. Bacchi CE, Gown AM. Detection of cell proliferation in tissue sections. 1993.Braz J Med Biol Res, 26(7): 677-87.
    19. Minca, E. et al. Automated and Visual Assessment of Ki-67 IHC in Breast Carcinoma: Comparison of 3 Antibody Clones. Laboratory Investigation, suppl. 2012; 93:57A pg. 33.
    20. Leonardo E, Volante M, Barbareschi M, Cavazza A, Dei TAP, Bussolati G, et al. Cell membrane reactivity of MIB-1 antibody to Ki67 in human tumors: fact or artifact? Appl Immunohistochem Mol Morphol.2007; 15(2): 220–223.
    21. VENTANA PD-L1 (SP142) Assay Package Insert, 2019.
    22. Schmid P, Adams S, Rugo HS, et al. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018;379(22):2108-2121.