Now detecting HER2 Low and Ultralow
Breast IHC AI is an AI-powered image analysis tool that accurately detects regions of invasive tumor, standardizes scoring of HER2, ER, PR,and Ki67, and enables detection of low and ultralow HER2 expression in breast cancer.
Intended Use
Breast IHC AI is For Research Use Only and not intended for clinical diagnostic use.
Inputs
WSI of resections, excisions, and/or biopsies from primary invasive breast cancer
Key Outputs
- HER2: HER2 Grade: Negative, Ultralow, Low, 2, 3; HER2 Score: 0, 1+, 2+, 3+; Percent positive
- ER and PR: Intensity Score: percent of weak, moderate, and strong positive cells; AllRed Score
- Ki67: Percent of positive cells
Supported Clones
- HER2: 4B5; CB11
- ER: EP1; SP1
- PR: PgR636; Pgr A/B: 16+SAN27
- Ki67: MIB1, SP6
Breast IHC AI may be compatible with additional clones. Contact info@indicalab.com for more information.
Breast IHC AI was validated using Hamamatsu NanoZoomer S360 and Leica Aperio GT 450 scanners.
Development & Validation of an AI-based Workflow for Clinical Scoring of HER2, ER, PR, & Ki67 Immunohistochemistry in Breast Cancer Tissue
Explore Breast IHC AI, a deep learning-based workflow for evaluation of breast cancer.
File Formats
- Non-proprietary (JPG, TIF, OME. TIFF, DICOM [DCM*])
- Leica (SVS, AFI, SCN, LIF)
- Hamamatsu (NDPI, NDPIS)
- Philips (iSyntax, i2Syntax)
- 3DHistech (MRXS)
- Nikon (ND2)
- Akoya (QPTIFF, component TIFF)
- Olympus / Evident (VSI)
- Zeiss (CZI)
- Ventana (BIF)
- KFBIO (KFB, KFBF)
*whole slide images
Validation and Clinical Implementation of Breast IHC AI
Learn how Kaiser Permanente deployed Breast IHC AI as a laboratory developed test.
Breast IHC AI Brochure
Learn how this AI-powered tool standardized breast cancer biomarker quantification to include HER2 low and ultralow.
HALO Clinical AI Solutions Flyer
Check out our flyer to learn more about HALO Clinical AI Solutions
Standardize Biomarker Evaluation
Breast IHC AI standardizes biomarker scoring and reduces interobserver variability in the IHC evaluation process, without compromising accuracy.
More Efficient Workflow
Automated biomarker evaluation reduces the workload for pathologists and researchers while delivering accurate and efficient results.
Complement Your Expertise
Breast IHC AI provides consistent, standardized measurements so you are free to apply your expertise where it’s needed most, in the interpretation of results to make informed decisions.
Comprehensive Analysis
Breast IHC AI includes AI-based analysis assays for automated scoring of HER2, ER, PR, and Ki67, including analysis of HER2 low and ultralow expression. Each assay has built-in artifact exclusion, benign epithelial region exclusion, and tumor detection steps to ensure that biomarker analysis is performed accurately and consistently each and every time. Tumor cells are analyzed for expression of HER2, ER, PR, and Ki67, and a comprehensive set of results and markups are generated for each image, including clinical score and percentage positivity.
Key Output Metrics
Accurately Detect HER2 Low and Ultralow Expression in Breast Cancer
The HER2 algorithm detects all levels of expression, including low and ultralow levels and outputs a Grade of Negative, Ultralow, Low, Grade 2, and Grade 3 with a corresponding Score of HER2 0, 1+, 2+, and 3+. 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®
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 Breast IHC AI or to learn more about our other clinical solutions.
You can also drop us an email at info@indicalab.com
Regulatory Compliance
Breast IHC AI is For Research Use Only and not intended for clinical diagnostic use. 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.