The Diagnostic Applications software is an in vitro diagnostic (IVD) medical device designed for image analysis and processing of digital pathology slides. Integrated with CaseManager DX and ClinicalViewer, it enables pathologists to analyze high-resolution images obtained from FFPE tissue specimens and cytology samples, supporting complex diagnostic and therapeutic decisions. Offering tools with various automation levels for precise measurements, it streamlines workflows while ensuring diagnostic accuracy. Intended for trained professionals, it serves as a decision-support tool in clinical practice.
Key features
Targeted, Field-of-View Image Analysis
Focuses on specific areas of interest within tissue samples for precise, relevant insights, supporting accurate diagnostic decisions.
Comprehensive Biomarker Assessment
Specialized modules for critical biomarkers, including Estrogen, Progesterone, HER2, Ki67, GEPNET, and PD-L1, enable detailed analysis to support complex case evaluations.
Automated Cell Counting
High-throughput, standardized cell quantification addresses the limitations of manual counting, enhancing speed, consistency, and reproducibility.
Manual and Semi-Automatic Adjustments
Offers flexibility with manual correction tools, allowing pathologists to refine segmentation and detection for complex or ambiguous regions.
Calibration and Standardization
Built-in features ensure consistency across cases, utilizing robust sample databases and quality control protocols for reliable, reproducible results.
Integration with CaseManager
Automatically organizes case data, displaying measurement results, charts, and masked images within the pathology workflow, facilitating diagnosis and collaboration.
Enhanced Result Management
Advanced features, including multi-view support and rescoring options, improve case processing, accessibility, and adaptability for varied diagnostic needs.
Secure, On-Premise Deployment
Offers a cost-effective, data-secure solution with local hosting, ensuring compliance with stringent privacy regulations while reducing risks associated with cloud-based systems.
Research and Education Support
Provides server-side storage for research scenarios and serves as a valuable training tool, offering annotated cases with algorithmic insights guided by experienced pathologists.
Data Integration and Archiving
Facilitates a data-driven clinical approach by integrating with patient information systems, supporting long-term storage, retrieval, and analysis of digital slides and algorithm outputs.
Additional features
Key Quantification BioMarkers
- Estrogen – The Estrogen tool helps the user to quickly and objectively measure the Allred Total Score on a selected region of the slide.
- Progesterone – The Progesterone tool helps the user to quickly and objectively measure the Allred Total Score on a selected region of the slide.
- HER2 – The HER2 tool helps the user to quickly and objectively measure the Field Score on a selected region of the slide.
- Ki67 – The Ki67 tool helps the user to quickly and objectively measure the proliferation Index on a selected region of the slide.
- GEPNET – The GEPNET tool helps the user to quickly and objectively measure the GEPNET score on a selected region of the slide.
PD-L1 – The MembraneQuant-based Lung PD-L1 tool helps the user to quickly and objectively measure TPS score on a selected region of the slide.
Installation
Diagnostic Applications is designed to operate within ClinicalViewer, requiring ClinicalViewer to be installed prior to setting up the application. It is not a standalone software and functions as an integrated tool for enhanced diagnostic workflows. No license file or dongle is needed. Accessibility is controlled via CaseManager.
System requirements
- Monitor/Display Resolution: 1280 x 720 or better
- Runs on Windows 11 OS (Minimum: Windows 10 22H2, Professional 64-bit
- All-in-one PC with Virtual Server (Minimum requirement- CPU: Intel 3.2 Ghz i5 (Quad Core), 4GB RAM)
- Disk Space: Minimum 800MB (Diagnostic Applications 3.1 – 150MB; ClinicalViewer 3.0 – 650MB)
Notes
- Both ClinicalViewer and Diagnostic Applications installer files can be downloaded from the CaseManager user interface.
