Pathology lab

Driving diagnostic certainty for life-changing decisions in pathology.


Pathology lab fleet of instruments with slides indicating various types of cancer

Advancing science, breaking barriers, and building the future

Empowering your pathology lab to reach its full potential

At Roche, we are personally committed to driving diagnostic certainty for life-changing decisions in pathology. We do this by advancing science to help improve patients’ lives and by delivering innovative solutions that break down the barriers that anatomic pathology labs face every day. This empowers our customers to reach their full potential now, and build a future that holds the potential to beat cancer.

Drawing on a deep understanding of anatomic pathology, we deliver a well-integrated, end-to-end solution that advances clinical decision-making in oncology. We keep our customers at the forefront through continuous improvements in staining automation, lab integration, and digitization while pushing the boundaries of medical science to provide high medical value with the most comprehensive assay portfolio available today.2

The pathology lab power button showcases how Roche advances science breaks barriers and builds the future

Amplify your impact on patient outcomes with high medical value solutions

Our commitment to high medical value innovation ensures that laboratories benefit from a leading-edge test menu across several disease areas, including the gold standard in breast diagnostics.1 We offer the most comprehensive menu of ready-to-use immunohistochemistry/in situ hybridization (IHC/ISH) assays, including the most companion diagnostic tests available today2 to link diagnoses with therapeutic options that can lead to better outcomes for patients.

Each of the 200+ assays in our extensive menu is built with clinical utility in mind. We uphold rigorous scientific standards throughout the development process to ensure you have robust and reliable products, maximizing your impact on patients’ lives. A focused survey of key customers in the US and Europe found that 44% of labs consider Roche the top provider of high-quality assays, compared to only 27% for the nearest competitor.3

The pathology lab power button showcasing how Roche advances science

Optimize and grow your pathology lab business with solutions built with you in mind

We consistently explore new opportunities to help you break down the barriers to success with fully automated systems, digital pathology, and integrated workflow solutions that enable you to deliver fast, reliable results for patients.

In addition, expert Roche personnel support your educational and technical needs to ensure successful setup, implementation, day-to-day operations, and troubleshooting of our solutions – so you can enjoy peace of mind and freedom to focus on the high-value tasks that can make a day’s work more rewarding.

The pathology lab power button showcasing how Roche breaks barriers

*Research use only, not for use in diagnostic procedures.

Partner with the largest investor in new and sustainable solutions4 that change healthcare standards

As the industry leader in diagnostic research and development, we remain the foremost investor in innovations that positively impact lives and shape the future.4

Renowned for our commitment to developing products that enhance lives while prioritizing environmental responsibility, we are also dedicated to assisting laboratories in achieving their sustainability objectives and staying ahead of evolving compliance standards. Roche is proud to stand as one of the world's top three sustainable healthcare companies in the Dow Jones Sustainability Index (DJSI).5

The pathology lab power button showcasing how Roche builds the future

Automated instrumentation for timely, reliable, and reproducible results.

The BenchMark ULTRA PLUS system uses an unprecedented, fully-automated workflow for immunohistochemistry (IHC) and in-situ hybridization (ISH) slide staining to decrease touchpoints.
Empowering special stains with consistent quality, workflow efficiency and improved safety through automated slide staining and ready-to-use reagents.

Break down lab barriers with connected and integrated instrumentation and software.

navify® Pathology Lab Hub delivers a solution which provides universal LIS connectivity for Roche's product portfolio and competitors’ products used in Anatomic Pathology laboratories. navify® Pathology Lab Hub may be used in histology and/or cytology and/or molecular labs. navify® Pathology Lab Hub addresses the connectivity needs of Roche's customers by providing a single interface point for all data routing between LIS systems and their product portfolio, and by routing data without manipulation or changes to the message content.The intended use of navify® Pathology Lab Hub is the following:Connect laboratories' LIS system(s) and product portfolio through a single middlewareReceive order information from the customer’s LIS system and route this to appropriate productsRoute data/information (status updates, reports, analysis data, etc.) back to the customers’ LIS system(s)Route data within Roche customers’ product portfolioThe different types of information are listed below.TypeDescriptionPatientData about a patient such as name, surname, date of birth, gender, contact, relationship with their cases...CaseData about thecase such as number, date of registration, demographic, relationship with their specimens, host identifier that has called the case...ContainerThe sample is allocated in the container. Some of the fields are the identification of the specimen, the location of the sample, the sample type (organ, tissue, mass, biopsy, liquid,...), relationship with their blocks,...SpecimenTissue sample held in a container.BlockThe block contains a piece of tissue to be evaluated. Some of the fields are the identification of the block or cassette, their status (marked, verified, embedded), relationship with their slides,...SlideIt contains one of the cuts which has been made from the sample. Some of the fields are the identification of the slide, the orientation of the cut, the stain protocol performed, its status (printed, staining, stained, assembled), location of pictures that have been done on the slide.Types of information processed through navify® Pathology Lab Hub.
The navify® Analytics for Pathology Lab makes use of data that has been aggregated and prepared by navify® Analytics platform to provide operational insights for customers with navify® Pathology Lab Advantage Workflow Solutions in laboratories, including but not limited to:Object volumesStain volumesSender volumesCompleted/pending case countsTurnaround timeAverage slides/caseIdentification of quality issue typesDashboards, calculations, and data display methods are subject to change.The dashboards available to an individual user are based on the user's defined role. Multi-site dashboards provide aggregated visualizations of multiple laboratories. Single- site dashboards provide visualizations of an individual laboratory.

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.

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.
The CINtec® PLUS Cytology test is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16INK4a and Ki-67 proteins in cervical specimens collected by a clinician using an endocervical brush/spatula or broom collection device and placed in the ThinPrep® Pap Test PreservCyt® Solution. The CINtec PLUS Cytology test includes a ready-to-use cocktail of primary antibodies which contains a mouse monoclonal antibody directed against human p16INK4a (p16) protein (clone E6H4), and a recombinant rabbit monoclonal antibody directed against human Ki-67 protein (clone 274-11AC3V1) for use on the BenchMark ULTRA instrument with 3,3ʹ-diaminobenzidine tetrahydrochloride (DAB) and Fast Red detection systems. The CINtec PLUS Cytology test is indicated: To be used in women 25 – 65 years old with 12 Other High Risk (HR) HPV positive test results using cobas® HPV for use on the cobas® 6800/8800 Systems (cobas® HPV) or the cobas® 4800 HPV Test in primary HPV screening, to determine the need for referral to colposcopy. To be used in women 25 – 65 years old with HPV16/18 positive test results using cobas® HPV or the cobas® 4800 HPV Test in primary HPV screening where the CINtec PLUS Cytology test results will be used in conjunction with the physician’s assessment of patient screening history, other risk factors, and professional guidelines to guide patient management. To be used in women 30 – 65 years old with NILM (Negative for Intraepithelial Lesion or Malignancy) and 12 Other HR HPV positive test results using cobas® HPV or the cobas® 4800 HPV Test in adjunctive cervical cytology and HR HPV screening, to determine the need for referral to colposcopy. To be used in women 30 – 65 years old with NILM (Negative for Intraepithelial Lesion or Malignancy) and HPV16/18 positive test results using cobas® HPV or the cobas® 4800 HPV Test in adjunctive cervical cytology and HR HPV screening where the CINtec PLUS Cytology test results will be used in conjunction with the physician’s assessment of patient screening history, other risk factors, and professional guidelines to guide patient management. Results from the CINtec PLUS Cytology test should be interpreted by a qualified pathologist.

Driving diagnostic certainty for life-changing decisions in precision oncology with the broadest menu of companion diagnostic tests available today.1

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 first FDA-approved immunohistochemistry (IHC) companion diagnostic for determining Claudin 18 (CLDN18) protein expression in patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma who may be eligible for CLDN18.2-targeted treatment with Astellas’ VYLOY® (zolbetuximab-clzb).

Integrated, open, end-to-end digital pathology and clinical decision solutions to enable better, more personalized healthcare.

The VENTANA DP 200 slide scanner is easy to use and optimized for automation with the capability to scan, digitize, store, retrieve, and view digitized images.

Breaking barriers to advance science

The DISCOVERY ULTRA research instrument is the solution for scientists and research professionals who demand more than what conventional immunohistochemistry (IHC) and in situ hybridization (ISH) research methods have to offer. The DISCOVERY ULTRA research instrument offers our highest level of protocol flexibility for the most challenging assays and for rapid assay development. The thirty independent slide drawers allow for titration capability for each individual slide. This instrument offers enhanced multiplexing and immunofluorescence capabilities. It also saves valuable development time with continuous access to bulks, waste and reagents.

Click on each slide to explore the Assay Portfolio

Laboratory technician at work in the laboratory

Online pathology education portal: Empower your practice

We support pathologists with resources to stay up-to-date on emerging biomarkers and technologies that are rapidly evolving the field of pathology. Our team has developed a variety of tools to elevate your knowledge and confidence in results. Advance your practice with educational content and interactive training to aid in the interpretation of our assays.

Contact us

Do you have questions about our products or services? We’re here to help. Fill out the form to contact a Roche representative.

Related health topics

*Estimated number of unique patients tested based on total 2022 sales volume

References

  1. NordiQC. (2020). Nordic Immunohistochemical Quality Control, HER2 run B30 2020
  2. Data on file. Roche Diagnostics International Ltd.
  3. Maia Strategy Group; Roche Tissue Diagnostics Advanced Staining II: Survey, Double Blinded. Accessed January 2022.
  4. Fierce Biotech. [Internet; cited 2024 Jun 18]. Available from: https://www.fiercebiotech.com/biotech/top-10-pharma-rd-budgets-2022
  5. GlobeNewswire. [Internet; cited 2024 Jun 18]. Available from: https://www.globenewswire.com/news-release/2023/12/15/2796818/0/en/Roche-named-among-top-three-most-sustainable-healthcare-companies-in-the-Dow-Jones-Sustainability-Indices.html