navify® Digital Pathology

by Roche Diagnostics  · Based in Switzerland →Fast, customizable platform enhancing the efficiency of the pathology laboratory workflow.
Pathology

Contact for pricing
Regulatory Status Disclosed

Overview

navify® Digital Pathology by Roche Diagnostics is an enterprise pathology software solution designed to enhance the efficiency of the pathologist’s workflow through laboratory integration and automation. It is part of the Roche Digital Pathology Dx whole slide imaging system, which includes VENTANA DP 200 and VENTANA DP 600 slide scanners. The system is FDA-cleared to aid pathologists in reviewing and interpreting digital images of scanned formalin-fixed paraffin-embedded (FFPE) pathology slides for primary diagnosis.

This intuitive, web-based application offers synchronized multi-slide viewing and annotating tools, facilitating seamless navigation through slides and cases. It promotes collaboration among experts through easy case-sharing features. navify® Digital Pathology provides access to fully integrated artificial intelligence-based image analysis algorithms, both from Roche’s uPath portfolio and third-party collaborators, through the Roche Digital Pathology Open Environment. These AI tools are designed to enhance pathology insights, particularly in cancer diagnostics, supporting precision medicine and targeted treatments.

The software is scalable and customizable, with options for on-premise and cloud-based deployments to adapt to varying lab volumes and institutional needs. It integrates with Laboratory Information Systems (LIS) and Picture Archiving and Communication Systems (PACS) via navify Pathology Lab Hub middleware, streamlining workflows and enabling automated data transfer. Roche emphasizes data safety and security, with navify® Digital Pathology being ISO 27001:2013 certified for information security management and ISO 27017:2015 and 27018:2019 certified for cloud hosting and personally identifiable information management.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Intuitive, web-based application with pathologist-centric design
  • Synchronized multi-slide viewing and annotating tools
  • Ease of case sharing for collaboration and second opinions
  • Integration with AI-based image analysis algorithms (Roche uPath and third-party)
  • Scanner interoperability (connects with VENTANA slide scanners)
  • Integration with LIS and PACS via navify Pathology Lab Hub middleware
  • Customizable reports and role-based portals
  • On-premise and scalable cloud-based deployment options
  • Data safety and security (ISO 27001, 27017, 27018 certified)
  • Fast case loading, image viewing, and report generation

Use Cases

  • Primary diagnosis using digital images of pathology slides
  • Enhancing pathologist workflow efficiency and automation
  • Remote consultation and collaboration among experts
  • Automated image analysis for various cancer biomarkers (e.g., HER2, PD-L1, ER, PR, Ki-67)
  • Case management and evaluation/report generation
  • Laboratory optimization and operational insights (when combined with navify Analytics)

What Physicians Need to Know

Whole Slide Image Support
Supports synchronized multi-slide viewing and annotating tools, including a multi-slide canvas viewer for up to six slides simultaneously. Enables fast case loading, image viewing, and report generation with client-side image caching. Compatible with VENTANA DP 200 and DP 600 slide scanners for high-quality digital image acquisition. Intended for in vitro diagnostic use with formalin-fixed paraffin-embedded (FFPE) tissue sections; not for frozen section, cytology, or non-FFPE hematopathology specimens.
Digital Pathology Integration
Fully integrated with Picture Archiving and Communication System (PACS) and navify Pathology Lab Hub middleware. Offers future-proof scanner interoperability and seamless integration with third-party algorithms via the Roche Digital Pathology Open Environment, allowing secure data exchange and access to a broad range of AI tools.
Stain Compatibility
Image analysis algorithms are designed for VENTANAu00ae slide scanner images stained with Roche Tissue Diagnostics assays. Specific compatibility includes stains for VENTANA HER2 Dual ISH DNA Probe Cocktail assay, VENTANA HER2 (4B5), PD-L1 (SP263), ER (SP1), PR (1E2), Ki-67 (30-9), and TROP2 (EPR20043) NSCLC Assay.
Biomarker Detection Capabilities
Provides access to high medical value AI-based image analysis algorithms, including uPath algorithms for HER2 (4B5), HER2 Dual ISH, PD-L1 (SP263), ER (SP1), PR (1E2), and Ki-67 (30-9). The Roche Digital Pathology Open Environment integrates over 20 AI algorithms from collaborators for enhanced pathology insights, supporting detection, grading, and tumor quantification for various cancers.
Turnaround Time Impact
Enhances workflow efficiency through fast case loading, image viewing, and report generation, including client-side image caching. Designed to reduce turnaround time for pathologist review and diagnosis. navify Analytics for Pathology Lab helps optimize staffing and identify bottlenecks to improve TAT without increasing headcount. Demonstrated a 16.3% reduction in routine TAT in a hospital implementation.
CAP/CLIA Compliance
Roche Digital Pathology Dx, including navify Digital Pathology, is cleared for specific clinical applications and intended for research and educational use for other applications. The VENTANA DP 200 system has received FDA 510(k) clearance for primary diagnosis in the US. The platform is ISO 27001:2013, ISO 27017:2015, and ISO 27018:2019 certified for information security and cloud data management, operating in accordance with jurisdictional laws and regulations. CAP accreditation checklists and CLIA regulations apply to digital pathology systems for patient safety, remote assessment, and validation.
Supported Cancer Types
AI algorithms and decision support tools are available for breast cancer (HER2, ER, PR, Ki-67, HER2 Dual ISH), non-small cell lung cancer (PD-L1, TROP2), prostate cancer, colorectal cancer, gastric cancer, and bladder cancer. The Navify tumor board also includes guidelines for breast, colorectal, non-small cell lung, and prostate cancers.
Quantitative Analysis Features
Offers high medical value AI-based image analysis algorithms embedded directly into the workflow for objective and reproducible results. uPath Image Analysis Algorithms provide accurate assessment of scanned slide images. navify Analytics for Pathology Lab provides operational insights including object volumes, stain volumes, sender volumes, completed/pending case counts, and turnaround time. AI algorithms support tumor detection, grading, and quantification.
LIS Integration
Fully integrated with navify Pathology Lab Hub middleware, which provides universal LIS connectivity for Roche and third-party instruments, simplifying IT infrastructure. Offers convenient and secure access with automated data transfer and LIS auto-deployment. navify Integrator facilitates bi-directional, standardized, and secure data integration between LIS, HIS, EMRs, and cloud-based products.
Physician Tip

Leverage the synchronized multi-slide viewing and annotation tools for comprehensive case review and efficient collaboration. Utilize the integrated AI-based image analysis algorithms for objective and reproducible assessment of biomarkers and cancer types, enhancing diagnostic confidence. Take advantage of the remote consultation capabilities to easily share cases for second opinions and access specialized expertise, improving patient care in diverse geographical settings. Be aware of the specific clinical applications for which the system is cleared for diagnostic use, and use it for research and educational purposes in other applications, always reviewing product labeling for compliance.

The navify Digital Pathology solution is designed for extensive integration, connecting seamlessly with VENTANA slide scanners and Roche's uPath enterprise software. Crucially, it integrates with navify Pathology Lab Hub middleware, which acts as a universal LIS connector, simplifying IT infrastructure by providing a single interface for data exchange between LIS systems and various lab instruments, including those from competitors. The Roche Digital Pathology Open Environment facilitates the integration of third-party AI algorithms, expanding the range of available image analysis tools and fostering an open ecosystem for innovation. It also supports connectivity with PACS and offers scalable deployment options (on-premise and cloud-based) to fit different laboratory needs and ensure compliance with jurisdictional regulations.

Details

Category Pathology AI
Pricing Contact for pricing Custom pricing based on deployment (on-premise or cloud), features, and integrated AI algorithms.
DeploymentOn-premise, Cloud
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

FDA-cleared as a whole slide imaging system (including VENTANA DP 200 and DP 600 slide scanners, digital pathology workflow software, and a display) to aid pathologists in reviewing and interpreting digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue for primary diagnosis.

Integrations
EHR Not specified
Specialties Pathology

What the Web Says

navifyu00ae Digital Pathology is an image management system designed to enhance the efficiency of pathology workflows through laboratory integration and automation. It offers features like synchronized multi-slide viewing, annotating tools, and seamless integration with third-party algorithms. The platform aims to improve collaboration among pathologists and specialists, streamline case sharing, and provide customizable reporting options.

Overall: Mixed

Strengths

  • Enhances workflow efficiency with faster case loading, image viewing, and report generation.
  • Offers synchronized multi-slide viewing and annotating tools, allowing pathologists to view up to six slides simultaneously.
  • Facilitates easy case sharing for second opinions and consultations, promoting collaboration.
  • Provides true integration with third-party AI-based image analysis algorithms, saving time and improving the user experience.
  • Intuitive, web-based application with a pathologist-centric design that is easy to adopt and adapt.
  • Offers flexible deployment options, including on-premise and scalable cloud-based configurations, ensuring compliance with regulations.

Limitations

  • Some users on Reddit have reported issues with the platform, such as IT permissions or configuration problems, and occasional internet/server-related hiccups.
  • Initial setup and configuration can be complex and time-consuming.
  • Integration with third-party applications can be challenging.
  • The cost of implementation and maintenance can be high.
  • Concerns about potential decreases in throughput for some pathologists compared to traditional microscopy, especially for cytology.

Based on reviews from: Roche Diagnostics (diagnostics.roche.com), PR Newswire, Clinical Lab Products, Roots Analysis, G2, Capterra, Reddit (r/medlabprofessionals), Reddit (r/pathology), Stock Titan, IntuitionLabs, YouTube (navifyu00ae channel)

Last updated: 2026-07-24

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Press & Coverage

Roche Diagnostics
Roche receives FDA clearance on its digital pathology solution for diagnostic use.
Roche announced FDA clearance for its digital pathology solution, the Roche Digital Pathology Dx (VENTANA DP 200) whole slide imaging system, for diagnostic use. This system aids pathologists in reviewing and interpreting digital images of scanned pathology slides for patient diagnosis.
2026-06
BfArM
Urgent Field Safety Notice for navify Digital Pathology by Roche Diagnostics GmbH
The German Federal Institute for Drugs and Medical Devices (BfArM) issued an Urgent Field Safety Notice regarding navify Digital Pathology by Roche Diagnostics GmbH. Further details are available in the manufacturer's advisory notice.
2026-05
Oxford Academic (American Journal of Clinical Pathology)
Roche Digital Pathology Dx whole slide imaging system is comparable to traditional microscopy for primary diagnosis in surgical pathology
This study concludes that Roche Digital Pathology Dx is noninferior to manual microscopy for primary diagnosis in surgical pathology, with performance results similar to other FDA-cleared whole slide imaging systems. The study served as a basis for FDA 510(k) clearances in June and December 2024.
2025-06
Imaging Technology News (ITN)
Lunit, Roche's Digital Pathology to Collaborate on Cancer Biomarker Testing
Lunit announced a collaboration with Roche to integrate Lunit SCOPE PD-L1 22C3 TPS into Roche's navify Digital Pathology platform, enhancing cancer biomarker testing and precision medicine. This integration marks the first deployment of Lunit's AI technology with Roche.
2024-09
Clinical Lab Products
Roche Expands Digital Pathology Platform with AI-Driven Algorithms
Roche's navify digital pathology enterprise software now integrates a range of AI-driven algorithms from collaborators like Deep Bio, Lunit, and Owkin, enhancing cancer diagnostics and enabling precision medicine. This expansion aims to revolutionize cancer research, diagnostics, and treatment.
2024-09
pharmaphorum
FDA clears Roche digital pathology platform for diagnosis
Roche's move into digital pathology is boosted by FDA approval of its Ventana DP 200 slide scanner, digital pathology workflow software, and display for clinical diagnosis. This clearance extends its use beyond research applications and positions Roche to challenge other players in the US market.
2024-06
Roche
Roche enters into collaboration agreement with PathAI to expand digital pathology capabilities for companion diagnostics
Roche and PathAI have partnered to deploy AI-powered image analysis algorithms on Roche's navify Digital Pathology platform, aiming to advance precision medicine by integrating AI interpretation and companion diagnostics. This collaboration builds on a previous agreement from 2021.
2024-02
PR Newswire
Roche collaborates with Ibex and Amazon Web Services to accelerate adoption of AI-enabled digital pathology solutions to help improve cancer diagnoses
Roche announced collaborations with Ibex Medical Analytics and Amazon Web Services to integrate Ibex's AI algorithms for breast and prostate cancer diagnosis into the navifyu00ae Digital Pathology platform. This initiative leverages cloud-based solutions to enhance clinical decision support and streamline pathology workflows.
2023-10

Videos

Product demos, reviews, and walkthroughs for navify® Digital Pathology.

View all on YouTube

Frequently Asked Questions

navifyu00ae Digital Pathology integrates AI-based image analysis algorithms, including those from third-party collaborators, to enhance efficiency and provide high-value insights. These AI tools can assist with tasks like image analysis, case prioritization, and identifying subtle features, ultimately aiming to improve diagnostic accuracy and streamline the pathologist's workflow.
navifyu00ae Digital Pathology is ISO 27001:2013 certified for information security management, and ISO 27017:2015 and 27018:2019 certified for cloud hosting and personally identifiable information management. It is designed to operate in accordance with relevant data privacy regulations like HIPAA and GDPR, ensuring robust security, enhanced authentication, and database encryption.
While powerful, AI in digital pathology faces limitations such as the need for high-quality, diverse datasets for training, and significant computational resources for handling large whole-slide images. Physicians should also note that some AI algorithms within the platform may be for Research Use Only (RUO) and not intended for primary diagnostic procedures, requiring careful review of product labeling.
navifyu00ae Digital Pathology is designed for seamless integration with Picture Archiving and Communication Systems (PACS) and navify Pathology Lab Hub middleware. It also features an open environment that allows for the integration of a diverse range of third-party AI-driven algorithms, creating a comprehensive ecosystem for pathologists.
While specific pricing details are not publicly disclosed, Roche offers tailored software plans designed to address unique lab needs and challenges, including a Clinical Decision Support (CDS) Plan that incorporates various algorithms. This suggests a flexible, potentially tiered, subscription-based model that accounts for features, usage, and the specific digital solutions adopted.
Yes, the digital pathology market includes several other companies offering AI-powered diagnostic solutions. Notable alternatives with robust AI capabilities include platforms from companies like Ibex Medical Analytics, Paige, PathAI, Qritive, and Aiforia, which also aim to enhance diagnostic accuracy and workflow efficiency.

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Suggest an Edit → | Last Verified: 2026-04-22 | First Added: 2026-04-22
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