Zero-Click Breast IHC Scoring Is Here: What’s New in HALO Breast IHC AI - Indica Labs

Zero-Click Breast IHC Scoring Is Here: What’s New in HALO Breast IHC AI

Automated biomarker scoring for breast cancer pathology just got smarter. The latest HALO Breast IHC AI release introduces new features designed to remove the remaining manual steps from HER2, ER, PR, and Ki67 workflow, delivering a true zero-click analysis experience from whole slide image to a scored result.

Here is everything that’s new, and what it means for your laboratory workflow.

This Update Collectively Advances:

Zero-click analysis triggered as soon as slides are scanned.
Automated DCIS and LCIS classification and exclusion from scored regions
Automated control tissue differentiation and exclusion*
Automated HER2 scoring including HER2 Null, Ultralow, Low, Equivocal, and Positive classifications
Automated Allred and intensity scoring with percentage positivity for ER and PR

AI-enabled Zero-Click Analysis: The Next Evolution of HALO AP 2.5 Lab Logic

Zero-Click Analysis with automated carcinoma in situ classification and control tissue* differentiation enables fully automated digital pathology workflows by initiating WSI analysis without manual pre-analysis steps, perfectly complementing HALO AP 2.5 Lab Logic, which then works as the intelligent orchestration layer, using AI-generated results to automatically route cases, trigger downstream workflow actions, and dynamically prioritize information for review. The result is a continuous, zero-click workflow from slide scan to pathologist sign-out, reducing manual effort while increasing efficiency and consistency.

Why is this feature important?

Eliminates manual preprocessing by automatically identifying invasive carcinoma and excluding DCIS, LCIS, and control tissue* before biomarker quantification, reducing hands-on effort and variability.
Automates end-to-end workflow orchestration by triggering AI analysis directly from the LIMS and intelligently routing cases based on AI-generated insights.
Adapts to evolving laboratory needs through configurable Lab Logic rules that enable laboratory leadership to modify workflow behavior, routing, and automation without IT intervention or custom development.

All demographic data displayed in this document are for illustrative purposes only.

How this improves your workflow: Together, Zero-Click Analysis and Lab Logic transform static digital pathology workflows into an intelligent, self-orchestrating process that improves efficiency, standardizes operations, and accelerates case turnaround.

Automated DCIS and LCIS Tissue Removal

One of the most impactful additions in this release is the automated classification and exclusion of ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS) from biomarker analysis.

Why is this feature important?

Prevents non-invasive tumor components from influencing HER2, ER, PR, and Ki67 scores.
Delivers standardized, guideline-compliant biomarker quantification with less manual intervention.

All demographic data displayed in this document are for illustrative purposes only.

How this improves your workflow: HALO Breast IHC AI now handles this classification automatically as part of its preprocessing flow, ensuring your scores reflect invasive carcinoma only, in accordance with clinical scoring guidelines, without requiring manual region selection.

Automated Control Tissue Differentiation and Exclusion

This release also introduces automated identification and exclusion of control tissue* from sample analysis. Internal controls are an essential part of IHC quality assurance, but their inclusion in scored regions introduces noise into biomarker quantification.

Why is this feature important?

Automatic differentiation of control tissue. *
Preserves the integrity of analysis without adding a manual exclusion step.

All demographic data displayed in this document are for illustrative purposes only.

How this improves your workflow: Accelerates case throughput without compromising analytical accuracy.

Automatic Scoring of ER, PR, HER2, and Ki67

Complete scope of automatic breast cancer biomarker scoring:

HER2 – Automated HER2 grading on invasive breast cancer cases, HER2 Null, Ultralow, Low, Equivocal, and Positive classifications with corresponding HER2 scores of 0, 1+. 2+. 3+, recommended by ASCO/CAP guidelines.
ER and PR – Automated Allred scoring, intensity scoring, and percentage positivity on invasive breast cancer cases, analyzed directly from IHC-stained WSIs in accordance with established clinical scoring guidelines.
Ki67 – Automated Ki67 proliferation index on invasive breast cancer cases, delivering reproducible and continuous quantification at scale.

All demographic data displayed in this document are for illustrative purposes only.

What does this do for your workflow: Streamlines digital pathology workflows by replacing time-intensive manual scoring with fast, standardized AI-assisted analysis. The result is improved consistency, increased laboratory throughput, and more efficient case review while keeping pathologists in control of the final decision.

HALO AP® Integration for Anywhere, Anytime Access

HALO Breast IHC AI is fully integrated within Indica Labs’ HALO AP® digital pathology platform, giving pathologists and authorized users seamless access to slides and assay results from any location. LIMS integration streamlines case assignment and assay initiation, while HALO AP®’s enterprise infrastructure ensures results are accessible wherever your team is working.

All demographic data displayed in this document are for illustrative purposes only.

Comprehensive Pipeline of Exclusions for Analytical Precision

Every automated output in HALO Breast IHC AI is underpinned by a comprehensive, sequential exclusion pipeline that preprocesses each WSI before biomarker analysis begins.

This pipeline systematically identifies and removes tissue components, including carcinoma in situ, control tissue*, necrosis, and other non-invasive regions, to ensure the final score reflects only the relevant invasive tumor area.
This approach offers users automation that complements the pathologist expertise, not circumventing it.

How this improves your workflow: Results are presented as an analysis assistance tool, with the pathologist retaining full interpretive authority over the final output.

Regulatory Compliance

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-000028v1

* Positive control tissue presented as tissue microarray (TMA) spots or compact, approximately rectangular tissue sections that are smaller than the sample. Other positive control tissue configurations may not be identified or classified accurately.