HALO AP Dx

HALO AP Dx is an FDA-cleared (510(k), K252762), case-centric digital pathology platform developed by Indica Labs, designed to support primary diagnosis, remote working, and other routine workflows in anatomic pathology. It is intended for pathologists and laboratory teams seeking to modernize diagnostic workflows with a secure, enterprise-grade solution. For primary diagnostic applications, HALO AP Dx is FDA cleared in the US, while the related HALO AP® platform is CE-IVDR marked for use in the EU, Switzerland, and the UK.

HALO AP Dx has been awarded a top score in the Best in KLAS Report and has been recognized for its ability to deliver faster, more accurate diagnoses without sacrificing quality. The platform unifies case management, collaboration, reporting, and image analysis into a single interface, enabling pathologists to review cases remotely the moment they are scanned.

Core Platform Capabilities

• Case-Centric Display: Automatically organizes images, metadata, gross details, and patient information into cases, with links to prior related cases. An ergonomic viewer makes it simple to evaluate, diagnose, and sign out cases.
• Intelligent Case List: Provides customizable, intuitive worklists tailored to specific workflows, automatically updated from your LIS or LIMS. Key details such as STAT or routine priority are surfaced to help pathologists focus on the most urgent cases first.
• Collaboration Tools: Built-in case conferencing supports real-time, multi-user diagnostic discussions. External consultation tools allow secure case sharing with outside experts for second opinions, supporting remote collaboration across internal and external institutions.
• Tumor Boards: Streamlines tumor board preparation by enabling assignment of cases, slides, and annotated regions in just a few clicks. Pathologists can instantly navigate to regions of interest and add case notes to keep discussions focused and efficient.
• Clinical Trials: Provides a single, intuitive interface for managing clinical trials across hospitals and CROs. Coordinators can create, manage, and monitor trials, and a blind scoring feature simplifies blinded workflows. (Not intended for clinical diagnostic purposes.)
• Reporting Options: Supports customized synoptic report building in accordance with CAP, ICCR, RCPath, or proprietary guidelines, enabling high-quality histopathologic data capture.
• Advanced Imaging: Enables advanced z-stack viewing across key pathology specialties including dermatopathology, hematopathology, and cytology. (Frozen sections, cytology, and non-FFPE hematopathology specimens are for Research Use Only.)
• DICOM-Compliant: Interfaces with the DICOM-compatible Aperio GT 450 DX Scanner and/or a PACS or VNA to import, store, and manage DICOM files.
• Advanced Image Archiving: The Deep Archive module enables AWS customers to leverage the lowest-cost S3 Glacier Deep Archive storage tier, delivering significant cost savings without compromising accessibility.

Laboratory Integration Workflow

1. Image whole slides and scan barcodes.
2. HALO AP Dx assembles the case using barcode and LIS data.
3. View the case and associated images within HALO AP Dx.
4. View patient and case data simultaneously in LIMS and HALO AP Dx.
5. Analyze, evaluate, and diagnose within the platform.
6. Generate a pathology report and automatically send it to the LIS via interface.

HALO AP Dx integrates with existing LIS and LIMS systems through open, API-first connectivity, delivering the right data at the right time within a single platform to streamline workflows and eliminate unnecessary steps.

Deployment Options

• On-Premises: HALO AP Dx can be deployed on-premise, seamlessly fitting into existing IT frameworks with enterprise-grade administration for secure scaling.
• Cloud-Hosted (AWS): Indica Labs offers fully managed, cloud-hosted HALO AP Dx environments on Amazon Web Services. The Cloud Services team handles all aspects of implementation and ongoing maintenance, ensuring high performance, scalability, and security with significantly reduced storage costs. Customers retain full ownership of their AWS account while AWS Certified Solutions Architects manage both the infrastructure and the HALO AP Dx software environment.

Platform Compatibility and Supported Formats

• Approved for use with the Aperio GT 450 DX Scanner and Dell U3223QE display for SVS and DICOM file formats.
• Approved for use with the Barco MDPC-8127 display for SVS file format.
• Approved for use with the Hamamatsu NanoZoomer S360MD slide scanner with Barco MDPC-8127 display for NDPI image format.
• FDA-Cleared File Formats: Leica Biosystems (SVS and DICOM) and Hamamatsu (NDPI).
• Devices: Windows PC and Macintosh.
• Browsers: Google Chrome and Microsoft Edge.

Training, Support, and Services

• Indica Labs' applications team provides hands-on training to ensure staff confidence from day one.
• Technical experts partner with customer IT departments to streamline deployment.
• Support is available for organizations transitioning from existing image management systems, with a proven migration process.
• Software Maintenance and Support (SMS) coverage plans are available.

HALO AP Dx provides built-in compliance with FDA 21 CFR Part 11 and HIPAA. The platform is cleared for primary diagnostic use in the USA with the Leica Biosystems Aperio GT 450 DX scanner and the Hamamatsu NanoZoomer S360MD slide scanner. Organizations interested in AI and image analysis capabilities can explore HALO AP®, the CE-IVDR marked platform that seamlessly integrates image analysis, AI, and third-party AI tools.