Pathology lab

The BenchMark ULTRA PLUS system uses an unprecedented, fully-automated workflow for immunohistochemistry (IHC) and in-situ hybridization (ISH) slide staining to decrease touchpoints.

Optimize efficiency and stain quality with the automated VENTANA HE 600 pathology laboratory staining system.

Empowering special stains with consistent quality, workflow efficiency and improved safety through automated slide staining and ready-to-use reagents.

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.

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.

The qualitative immunohistochemical detection of PRAME by light microscopy in sections of formalin-fixed, paraffin-embedded tissue stained on a BenchMark IHC/ISH instrument.

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.

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.

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).

Workflow flexibility meets high-capacity with the VENTANA DP 600 slide scanner featuring a slide tray-based system and built-in calibrations.

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.

Software for objective, reproducible, automated scoring of VENTANA DP 200 slide images (breast) stained with the VENTANA HER2 Dual ISH DNA Probe Cocktail assay.

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.