HALO Prostate AI

AI-assisted prostate cancer detection and Gleason grading for core needle biopsies in pathology workflows.

Overview

HALO Prostate AI, from Indica Labs, is a CE-IVD certified deep learning-based screening tool designed to assist pathologists in the identification and grading of prostate cancer in core needle biopsies. The algorithm automatically analyzes all appropriate case slides and notifies pathologists of cases with suspected findings directly within their native workflow, making it a powerful aid for diagnostic efficiency and accuracy.

The tool is deployed and fully integrated into HALO AP®, Indica Labs' AI-powered, pathologist-driven platform for anatomic pathology workflows. It is suitable for use as a screening tool to support triage or as a post-diagnostic quality control check, fitting seamlessly into existing laboratory processes.

Comprehensive Analysis Capabilities

Automatic cancer detection and localization across all appropriate case slides
Tumor size measurement and reporting
Gleason grading of detected cancer regions
Detection of high-grade prostatic intraepithelial neoplasia (PIN)
Identification of intraductal carcinoma

Workflow Integration and Deployment

CE-IVD marked with best-in-class clinical sensitivity and specificity
Deployable as a screening tool for triage support or as a post-diagnostic QC check
Results can be shared with LIS and LIMS systems from any vendor
Deploys within your own IT environment — cloud or on-premise — ensuring full data control
Extendable with IHC image analysis capabilities through further integration with Indica Labs tools

Supported File Formats

Non-proprietary formats: JPG, TIF, OME.TIFF
Nikon: ND2
3DHistech: MRXS
Akoya: QPTIFF, component TIFF
Olympus / Evident: VSI
Hamamatsu: NDPI, NDPIS
Aperio: SVS, AFI
Zeiss: CZI
Leica: SCN, LIF
Ventana: BIF
Philips: iSyntax, i2Syntax
KFBIO: KFB, KFBF
DICOM: DCM (whole-slide images)

HALO Prostate AI is CE-marked for in-vitro diagnostic use in Europe, the UK, and Switzerland, and is accessed via the HALO AP® enterprise digital pathology platform. HALO AP® is also CE-IVDR marked and provides built-in compliance with FDA 21 CFR Part 11, HIPAA, and GDPR. In the USA, HALO Prostate AI is currently for research use only and is not FDA cleared for clinical diagnostic use.