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.

Find your product Contact us
Team of professionals with microscopes and laptop computer working with pathology lab assays in digitally enabled laboratory

Amplify your impact on patient journeys

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

Our commitment to innovation means a leading-edge menu for labs, and new hope for patients. Every assay we develop is designed with the highest quality in mind.  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.1 As a result, More laboratories choose Roche pathology lab assays for quality than any other provider.2

Medical Value: We offer the largest menu of companion diagnostic tests, helping to link patients to 17 different personalized therapies in many different cancers, and counting.3

Quality: A feasibility study, including a minimum of at least 15 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.

Menu Excellence: The largest menu of ready-to-use assays with over 250 immunohistochemistry (IHC) and in situ hybridization (ISH) assays in key disease areas to enable treatment decisions to be made quickly and confidently.1

Featured products

VENTANA MET (SP44) RxDx Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-MET, clone SP44, intended for use in the assessment of MET protein in formalin-fixed paraffin embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) specimens by light microscopy. This assay is for use with OptiView DAB IHC Detection Kit for staining on a BenchMark ULTRA or BenchMark ULTRA PLUS instrument.MET protein expression clinical cut-off is ≥ 50% of tumor cells exhibiting strong membrane and/or cytoplasmic staining (3+) in non-squamous NSCLC.VENTANA MET (SP44) RxDx Assay is indicated as an aid in identifying non-squamous NSCLC patients who may be eligible for treatment with EMRELIS™ (telisotuzumab vedotin-tllv).The results of VENTANA MET (SP44) RxDx 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.
The VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail is a dual color assay that enables clonality assessment in all B-cell lymphoma subtypes and plasma cell neoplasms.
CINtec PLUS Cytology is a dual-stain cervical cancer biomarker test that empowers clinicians to determine if their patients need immediate intervention or routine follow-up testing.
Find your product

Click on each slide to explore the Assay Portfolio

Contact us

Do you have any questions about this category or health topic? We’re here to help. Fill out the form to have a Roche representative contact you.

Explore more

References
  1. F. Hoffmann-La Roche Ltd. Number of staff pathologists [cited 2024 April 18]. 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. 2023 Assays, reagents, and strips competitor information [cited 2024 October 10]. Data on file.