IHC/ISH assays and detection

Taking labs further on their journey to impact patients' lives with the industry's most robust menu of reliable, ready-to-use assays across a multitude of disease areas.

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Amplify your impact on patient journeys

Our diagnostic assays help you provide more of the answers clinicians and patients need

Driving diagnostic certainty for life-changing decisions, we push the boundaries of medical science to deliver the world’s largest menu of more than 250 pathology lab assays and detection products. Every assay we develop is designed with the highest quality in mind—so you can consistently deliver reliable results. Roche antibodies are ready-to-use on VENTANA® fully-automated immunohistochemistry/in situ hybridization (IHC/ISH) instruments, increasing lab efficiency and reducing the time-to-result and resources required with manual or semi-automated solutions.

Scientific validity: Rigorous scientific evaluation and assessment is the first development requirement for every assay in our pipeline

Analytical performance: We comprehensively assess the ability of every assay to correctly and sustainably detect and/or measure a particular analyte, including analytical sensitivity, specificity, precision (repeatability & reproducibility), and accuracy

Clinical performance: A feasibility study, including a minimum of at least15 assay parameters and 20 tissue types, is completed for every assay we develop—ensuring robust performance in customers’ hands across sample types, instruments, and other real-world variables

In addition to a full range of diagnostic tests across key disease areas, only Roche offers the broadest menu of high medical value assays and innovations that deliver new levels of capability and confidence for labs and pathologists.1

Pioneering innovation that can help clinicians make decisions that may lead to better outcomes

The quality and clinical value of every VENTANA® assay* begins in development with our proven design controls–to deliver diagnostic confidence for life-changing decisions through:

Clinical benefit: With proven accuracy, our assays help you deliver the right test with clinical confidence and in a timely manner.

Analytical advantage: Highly specific and sensitive antibodies, accurate probes, and powerful detection systems help you diagnose precisely and confidently.

Testing efficiency: Our comprehensive solutions deliver fully automated assays on robust platforms, with digital pathology and workflow solutions that free up resources, help minimize labor costs, and reduce time to results.

Continually transforming healthcare standards

More laboratories choose Roche pathology lab assays for quality than any other provider.2

Because we are committed to helping you drive diagnostic certainty with every answer you provide, we employ an unprecedented team of over 50 pathologists and disease specialists who evaluate every assay, at every stage of development, beginning with ideation and continuing through the life of the product.3

Featured products

VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is intended for the qualitative detection of Kappa mRNA and Lambda mRNA in formalin-fixed, paraffin-embedded (FFPE) human bone marrow and lymphoid tissue stained on a BenchMark IHC/ISH instrument using chromogenic in situ hybridization (ISH) and visualized using light microscopy. VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is intended as an aid in the identification of B-cell lymphomas and plasma cell neoplasms.Results of the assay should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.This product is intended for in vitro diagnostic (IVD) use.
Roche Cell Collection Medium is designed for the preservation and transport of cells to be used in molecular testing and/or for the preparation of cytology slides.
PRAME (PReferentially expressed Antigen in MElanoma) is a tumor biomarker expressed in most cutaneous and ocular melanomas.
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Benefits of IHC/ISH pathology lab assay solutions from Roche across key disease areas

The leader in breast cancer diagnostics

IHC and ISH analysis provides important information related to tumor biology, helps profile breast cancer subtypes, and may improve treatment decisions.4 As the leader in breast cancer diagnostics, Roche offers numerous cancer diagnostic assays that enable pathology labs to deliver accurate results with confidence. We provide a robust menu of over 25 breast cancer diagnostic assays.

With proven accuracy, VENTANA breast cancer diagnostic assays provide timely and confident clinical results. Our robust assays, delivered on fully automated platforms, integrate with digital pathology and workflow solutions. By helping to free up resources, lower labor costs, and accelerate time to results, our comprehensive breast cancer workflow enhances operational effectiveness while enabling you to deliver the right test for each patient.

Improving dermatopathology diagnostics and treatment together

Melanoma is a malignancy of the melanocytes, and histology is the gold standard for distinguishing malignant cells from benign cells.5 Our robust menu of tools aid in dermatopathology diagnostics and treatment.

Roche provides over 50 cornerstone and novel dermatopathology ready-to-use reagents, including key IHC and fluorescein Isothiocyanate (FITC) antibodies, which aid in melanoma diagnosis, basal cell carcinoma diagnosis, squamous cell carcinoma diagnosis, and diagnosis of other dermatological malignancies.

Enabling you to assess familial risk for early intervention in colorectal cancer

For colorectal cancer, testing to identify abnormal tissue growth or symptoms includes physical exams, a stool test to check for blood, blood test to look for anemia, liver enzymes, or biomarkers.6

We offer a robust menu of more than 10 tools to aid in colorectal cancer diagnosis.

High sensitivity and specificity assays for prostate cancer

Prostate cancer is a major public health concern. It is the most commonly diagnosed cancer in men and the second leading cause of cancer death for men in the U.S.7

We offer a wide menu of more than 10 IHC assays to diagnose and subtype prostate cancer.

Bringing cervical cancer elimination within reach

Our portfolio of proven molecular and tissue-based tests utilizes the science of human papillomavirus (HPV) and biomarker technology to deliver highly sensitive and specific results,8-10 helping bring more clarity of answers for clinical decisions. The Roche cervical cancer portfolio provides three clinically validated tests to help identify women at risk of cervical cancer and improve detection and confirmation of high-grade disease in a single round of screening.

The right test at the right time helps minimize the potential for over- or under-treatment. With proper vaccination, screening and treatment, no woman should die from cervical cancer.

Roche also offers the first FDA approved IHC companion diagnostic test for epithelial ovarian cancer (EOC),11 enabling a treatment pathway for advanced stage, second line platinum resistant EOC.12

Additionally, Roche offers its VENTANA MMR RxDx Panel, the first companion diagnostic to identify endometrial cancer patients eligible for anti-PD1 immunotherapy.13

Driving diagnostic certainty with the most trusted hematopathology panel14,15

Hematological cancers vary significantly in both prognosis and aggressiveness, demonstrating a need for tools that assist pathologists in making confident diagnoses and helping to inform clinical decisions.16-18

We offer over 60 cornerstone and novel hematopathology ready-to-use assays, including key IHC antibodies and ISH probes, which aid in lymphoma diagnostics, leukemia diagnostics, myeloma diagnostics, and other hematopoietic malignancies.

Our globally preferred menu now features the new VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail Assay in countries accepting the CE Mark.19 This is the first clinically approved, highly-sensitive ISH test designed to help pathologists differentiate a B-cell malignancy from a normal, reactive response to an infection.20

Proven portfolio of lung cancer assays

Lung cancer is a significant global health issue and the leading cause of cancer deaths worldwide. In 2022, there were an estimated 2.4 million new lung cancer cases diagnosed.21

Roche offers the most comprehensive menu22 for lung cancer diagnostics with over 30 solutions. Our assays can assist in the stratification of diseases including non-small cell lung carcinoma (NSCLC), neuroendocrine carcinoma, and their various subtypes.23

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References
  1. F. Hoffmann-La Roche Ltd. 2023 Assays, reagents, and strips competitor information [cited 2024 October 10]. Data on file.
  2. F. Hoffmann-La Roche Ltd. Maia Strategy Group; Roche Tissue Diagnostics Advanced Staining II [Survey, cited 2022 January]. Data on file.
  3. F. Hoffmann-La Roche Ltd. Number of staff pathologists [cited 2024 April 18]. Data on file.
  4. Godoy-Ortiz A, et al. Deciphering HER2 breast cancer disease: biological and clinical implications. Front Oncol. 2019;9:1124.
  5. Damanpour, S. Grichnik, J. Conceptual approach to early melanoma detection: models, issues and challenges. Melanoma Manag. 2015;4: 327-337.
  6. American Cancer Society. Tests to diagnose and stage colorectal cancer [Internet; cited 2024 July 8]. Available from: https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagnosis-staging/how-diagnosed.html.
  7. World Cancer Research Fund International. Prostate cancer statistics [Internet; cited 2024 July 8]. Available from: https://www.wcrf.org/cancer-trends/prostate-cancer-statistics/
  8. F.Hoffmann-La Roche Ltd. cobas® HPV. [Method sheet; cited 2024 10 October].     
  9. Ventana Medical Systems, Inc. CINtec® Histology. [Method sheet; cited 2024 10 October].   
  10. Ventana Medical Systems, Inc.CINtec® PLUS Cytology. [Method sheet; cited 2024 10 October].
  11. VENTANA FOLR1 (FOLR1-2.1) RxDx Assay Package Insert. 2022.
  12. Matulonis UA, et al. Efficacy and safety of mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer with high folate receptor alpha expression: results from the SORAYA study. J Clin Oncol. 2023;41:2436-2445.
  13. F. Hoffmann-La Roche Ltd. Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for anti-PD1 immunotherapy [Internet; cited 2024 July 8]. Available from: https://diagnostics.roche.com/global/en/news-listing/2021/roche-receives-fda-approval-for-first-companion-diagnostic-to-identify-endometrial-cancer-patients-eligible-for-anti-pd1-immunotherapy.html.
  14. F. Hoffmann-La Roche Ltd. EQA data [cited 2024 October 10]. Data on file.
  15. F. Hoffmann-La Roche Ltd. Internal training document [cited 2024 October 10]. Data on file.
  16. Tilly H, et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26:116-25.
  17. Ladetto M, et al. ESMO consensus conference on malignant lymphoma: general perspectives and recommendations for prognostic tools in mature B-cell lymphomas and chronic lymphocytic leukaemia. Ann Oncol. 2016;27:2149-2160.
  18. Zucca E, et al. Marginal zone lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020;31:17-29.
  19. F. Hoffmann-La Roche Ltd. Data on file.
  20. F. Hoffmann-La Roche Ltd. VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail. [Method Sheet; cited 2024 April 16]. Data on file.
  21. World Cancer Research Fund International. Lung cancer statistics [Internet; cited 2024 July 8]. Available from: https://www.wcrf.org/cancer-trends/lung-cancer-statistics/.
  22. F. Hoffmann-La Roche Ltd. Diagnostic solutions supporting lung cancer [cited 2024 October 10]. Data on file.
  23. Yatabe Y, et al. Best practices recommendations for diagnostic immunohistochemistry in lung cancer. J Thorac Oncol. 2019;14:377-407.