Breast IHC AI is an automated, AI-based decision-support tool that standardizes scoring of HER2, ER, PR, and Ki67 IHC on whole slide images (WSI) in accordance with clinical scoring guidelines. It is seamlessly integrated into the HALO AP® diagnostic digital pathology platform.
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 score, percent HER2 1+, 2+, 3+ cells
- ER and PR: Allred Score; Intensity Score; percent of weak, moderate, and strongly positive cells
- 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.
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.
Supported Scanners
Leica Aperio GT 450 and Hamamatsu NanoZoomer S360
Supported File Formats
SVS, NDPI, NDPIS
Breast IHC AI may be compatible with additional file formats. Contact info@indicalab.com for more information.
Breast IHC AI Brochure
Learn more about the automated workflow and benefits of HALO Breast IHC AI (RUO).
Standardize Biomarker Evaluation
Breast IHC AI allows you to standardize your reporting, reducing variability in the IHC evaluation process.
More Efficient Workflow
By automating time-consuming manual tasks, Breast IHC AI significantly reduces the workload for pathologists and researchers. This efficiency boost allows for faster decisions without compromising accuracy.
Complement Your Expertise
Breast IHC AI serves as an additional tool to aid your analyses. By handling tedious tasks and providing consistent, standardized measurements, it frees you 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. 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 a clinical score and percentage positivity.
Key Output Metrics
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 US and is not FDA cleared for clinical diagnostic use. In addition, HALO AP provides built-in compliance and certifications with FDA 21 CFR Part 11, ISO 13485:2016, HIPAA, and GDPR.