Before Markup

AI-Powered Diagnostic

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 in their native workflow.

Comprehensive Analysis

The algorithm reports a comprehensive set of results and markups, including cancer detection and localization, tumor size, Gleason grading, the presence of high-grade PIN and intraductal carcinoma.

Seamlessly Integrated, AI-Enhanced Workflow

  • CE-IVD marked with best-in-class clinical sensitivity and specificity
  • Deploy as a screening tool to support triage or as a post-diagnostic QC-check
  • Results can be shared with LIS | LIMS systems from any vendor
  • Deploys in your own IT environment – cloud or on-premise – so you maintain full control of the data
  • Extend your image analysis capability with further integration of IHC image analysis from Indica Labs

File Formats:

  • Non-proprietary (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)
  • DICOM (DCM*)
    *whole-slide images

HALO Prostate AI Brochure

HALO Prostate AI offers pathologists a CE-IVD certified deep learning-based tool that can reduce turnaround times while demonstrating negative predictive values of 99% or greater in validation studies.

Novel CE-IVD Clinical Workflow for Analysis of Prostate Cancer Core Needle Biopsies

Learn more about Indica Labs’ novel CE-IVD certified deep learning clinical workflow for prostate cancer grading.

Seamless Deployment in HALO AP®

HALO Prostate AI is deployed and fully integrated into HALO AP®, the AI-powered, pathologist-driven platform for anatomic pathology workflows from Indica Labs.

Regulatory Compliance

HALO AI Prostate is CE-marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AI Prostate is For Research Use Only in the US and is not FDA cleared for clinical diagnostic use. HALO AI Prostate is accessed via the HALO AP® enterprise digital pathology platform.

HALO AP® is CE-IVDR marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AP is For Research Use Only in the US and is not FDA cleared for clinical diagnostic use. In addition, HALO AP provides built-in compliance with FDA 21 CFR Part 11, HIPAA, and GDPR.

Press Release: Indica Labs achieves CE-IVD certification for AI-based Prostate Cancer Detection and Gleason Grading Tool

Press Release

ALBUQUERQUE, NM – May 24, 2022 – Indica Labs, the leading provider of computational pathology software and services, is excited to announce a CE-IVD Mark for HALO Prostate AI, a deep learning-based screening tool designed to assist pathologists in identifying and grading prostate cancer in core needle biopsies.

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