HALO Breast IHC AI
The HALO Breast IHC AI Suite enables fully automated, zero-click biomarker analysis with automated carcinoma in situ classification and control tissue removal prior to biomarker scoring. Delivering automated, guideline-aligned quantification of HER2, ER, PR, and Ki67 in invasive breast cancer.
Seamlessly Integrated into HALO AP® for an AI-Enhanced Workflow
HALO Breast IHC AI is an AI-powered image analysis tool that accurately detects regions of in situ carcinoma, positive controls, and areas of invasive tumor, prior to HER2, ER, PR, and Ki67 biomarker scoring.
Intended Use
Research Use Only (RUO)
Inputs
WSI of resections, excisions, and/or biopsies from primary invasive breast cancer
Supported Clones
- HER2: 4B5; CB11; BMA
- ER: EP1; SP1
- PR: PgR636; Pgr A/B: 16+SAN27
- Ki67: MIB1, SP6
HALO Breast IHC AI may be compatible with additional clones. Contact info@indicalab.com for more information.
Comprehensive Biomarker Analysis
HALO Breast IHC AI standardizes biomarker scoring and reduces interobserver variability in the IHC evaluation process, without compromising accuracy.
Key Outputs: Pre-processing
- Tissue Detection (Background, Control Tissue, Analyzable Tissue)
- Image QC (Artifacts, Analyzable Tissue)
- Invasive Tumor (Area and Percentage)
- Benign (Area and Percentage)
- DCIS / LCIS (Area and Percentage)
- Other (Area and Percentage)
Key Outputs: Biomarker Scoring
- HER2:
- Grade: Null, Ultralow, Low, Equivocal, Positive
- HER2 Score: 0, 1+, 2+, 3+
- ER and PR:
- Intensity Score: percent of weak, moderate, and strong positive cells;
- AllRed Score
- Ki67: Percent of positive cell
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)
- KFBIO (KFB, KFBF)
- DICOM (DCM*)
*whole-slide images
Detects Carcinoma in situ and Positive Control Before Analysis
Zero-Click Analysis with automated carcinoma in situ classification and control tissue differentiation enables fully automated digital pathology workflows.
Internal controls are an essential part of IHC quality assurance, but their inclusion in scored regions introduces noise into biomarker quantification.
Differentiation of control tissue from analyzable tissue automatically preserves the integrity of analysis without adding a manual exclusion step.
Comprehensive Analysis of HER2, ER, PR, and Ki67
Automated HER2 grading analyzing HER2 IHC stained slides on invasive breast cancer cases including HER2 Null, Ultralow, Low, Equivocal and Positive classifications.
Automated Allred and intensity scoring in addition to percentage positivity analyzing ER and PR IHC stained slides on invasive breast cancer cases.
Automated Ki67 index analyzing Ki67 IHC stained slides on invasive breast cancer cases.
The software assists the pathologist by automatically reporting the percentage of positive cells and biomarker scores at the slide level, along with image analysis masks which can be viewed in the HALO AP® platform.
Seamless Deployment in HALO AP®
HALO Breast IHC AI is deployed and fully integrated into HALO AP®, the AI-powered, pathologist-driven platform for anatomic pathology workflows from Indica Labs.
Want to Learn More?
Fill out the form below to request a live demo of HALO Breast IHC AI or to learn more about our other clinical solutions.
You can also drop us an email at info@indicalab.com
Products & Services
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Software Maintenance & Support Coverage
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Technical Support
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HALO Breast IHC AI is For Research Use Only and not intended for clinical diagnostic use. HALO Breast IHC AI 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 USA 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. WBS-MAR-000029v1