Mindpeak Breast

by Mindpeak  · Based in Germany →Precision That Impacts Lives.
Oncology Pathology Radiology

Not disclosed

Overview

Mindpeak Breast (part of the Mindpeak Breast Suite) is an AI-powered digital pathology software designed to assist pathologists in analyzing and scoring immunohistochemistry (IHC) breast cancer biomarkers. The tool automates the detection, classification, and quantification of key breast cancer receptors, specifically targeting HER2, Ki-67, ER (Estrogen Receptor), and PR (Progesterone Receptor).

Developed for clinical laboratories, hospitals, and digital pathology practices, the tool integrates directly into existing workflows. It is compatible with major Whole Slide Image (WSI) scanners and is accessible through leading digital pathology platforms and Laboratory Information Systems (LIS), such as Paige, Sectra, and ZayaAI.

Notable Capabilities:

  • Automated IHC Quantification: Automatically detects and classifies tumor cells within whole slide images, distinguishing between stained (positive) and unstained (negative) cells to generate precise proliferation and expression scores.
  • HER2 Scoring: Classifies membrane staining intensity (0, 1+, 2+, 3+) in accordance with ASCO/CAP guidelines, supporting the identification of HER2-low and HER2-ultralow cases.
  • Ki-67 Proliferation Indexing: Offers automated hotspot and global scoring methods (such as the Ki-67 HS and Ki-67 4R protocols) to evaluate tumor proliferation.
  • Out-of-the-Box Adaptability: Designed to work with real-world image variability across different staining systems and scanners without requiring manual, lab-specific fine-tuning.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered image analysis for breast pathology
  • Standardized interpretation of biomarker analysis
  • Reduced inter-observer variability in diagnostics
  • Automated tissue analysis for faster results
  • Detection and classification of IHC stained tumor cells
  • Quantification of HER2, Ki-67, ER, PR, and p53 expression in breast cancer
  • Automated tissue segmentation and tumor detection on H&E slides
  • 0-click AI solutions for automated image analysis
  • Integration with existing lab workflows, scanners, LIS, and cloud storage
  • Support for drug development, patient stratification, and clinical trials

Use Cases

  • Primary breast cancer diagnosis
  • Automated assessment of breast cancer biomarkers (HER2, Ki-67, ER, PR, p53)
  • Streamlining pathology workflows and improving efficiency
  • Supporting macro-dissection workflows
  • Biomarker discovery and development for pharmaceutical companies
  • Prognostic risk profiling of breast cancer

Details

Category Oncology AI, Pathology AI
Pricing Not disclosed Contact for pricing information
DeploymentOn-premise (without cloud connectivity for data privacy and security), integrated into partner platforms (e.g., Paige Platform, Sectra PACS, PathAI's AISight Dx IMS)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Unknown AI-estimated

Mindpeak's AI algorithms were among the first to be deployed for routine clinical diagnostics in both the US and EU. However, specific FDA clearance for 'Mindpeak Breast' as a singular product is not explicitly stated in the search results, though some individual breast cancer modules are CE-IVD marked.

Integrations
EHR Not specified
Specialties Oncology, Pathology, Radiology

What the Web Says

Mindpeak Breast offers AI-powered solutions designed to assist pathologists in the detection and quantification of breast cancer cells and metastases from digital histopathology images. The software aims to improve diagnostic efficiency, accuracy, and consistency by automating tedious tasks and enhancing interobserver agreement. It has received CE-IVD mark and is being integrated into various digital pathology workflows in Europe and the US.

Overall: Positive

Strengths

  • Increases diagnostic efficiency and reduces manual analysis time for pathologists.
  • Enhances diagnostic accuracy and improves interobserver agreement among pathologists.
  • Provides reliable quantification of key biomarkers like HER2, Ki-67, ER, and PR.
  • Demonstrated high accuracy in comparative studies, outperforming other commercial AI solutions for HER2-low scoring.
  • Seamlessly integrates with leading digital pathology platforms, offering a complete workflow experience.
  • Reduces reporting time significantly, in some cases by 80% or more.

Limitations

  • Pricing details are not readily available and require direct vendor contact.
  • Limited public reviews available on platforms like G2 and Capterra, making it difficult to gauge widespread user sentiment from those sources.
  • While AI assists, human judgment and review remain essential to eliminate false positives.
  • Some alternatives are highly rated for customer support and customization, which are not explicitly highlighted for Mindpeak Breast in the provided information.
  • Potential for a learning curve with any new system, although onboarding staff are generally knowledgeable for similar systems.

Based on reviews from: Real Reviews, Cypath, PMC (PubMed Central), Business Wire, Mindpeak, G2, Tissuepathology.com, BioSpace, Mynewsdesk, Paige, Capterra, YouTube (WION)

Last updated: 2026-07-11

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Press & Coverage

Business Wire
Mindpeak to deploy and evaluate AI-Powered Digital Pathology Risk Assessment Tools for Breast Cancer in collaboration with AstraZeneca
Mindpeak and AstraZeneca have partnered to conduct an observational study evaluating Mindpeak's Breast H&E solution, an AI-powered software for analyzing breast cancer patient samples, aiming to improve primary breast cancer diagnosis in regions with limited resources.
2025-03
FirstWord Pharma
ASCO25: AstraZeneca, MindPeak study finds AI refines HER2 classification
A study funded by AstraZeneca and presented at ASCO25 showed that Mindpeak's AI tool significantly improved the identification of HER2-low and HER2-ultralow breast cancers, increasing sensitivity for HER2 scoring from 76% to 90%.
2025-05
BioWorld
Mindpeak raises $15.3M for AI-based pathology solutions
Mindpeak secured $15.3 million in Series A funding to accelerate the development and deployment of its AI-based pathology solutions, including algorithms for breast cancer diagnosis like Breast Ki-67 HS and Breast Ki-67 RoI.
2024-10
PMC - NIH
Artificial intelligence's impact on breast cancer pathology: a literature review - PMC - NIH
This review highlights the profound impact of AI on breast cancer diagnosis and management, specifically mentioning Mindpeak's modules like Breast HER2 ROI, Breast Ki-67 HS, and Breast ER/PR for automated analysis of breast carcinoma tissue samples.
2024-02
Business Wire
Mindpeak's AI Comes out on Top in Comparative Study on HER2-low Scoring by Cypath and Institut Gustave Roussy
A comparative study demonstrated Mindpeak's CE-marked HER2 AI for breast cancer diagnosis outperformed three other commercial AIs in HER2-low scoring.
2023-04
Tissuepathology.com
Tribun Health Enters a Strategic Partnership With Mindpeak to Provide Pathologists With the Most Advanced AI Diagnostic Tool for Breast Cancer
Tribun Health and Mindpeak announced a strategic partnership to integrate Mindpeak's breast cancer algorithms into Tribun Health's CaloPix 5 image management software, aiming to enhance precision and speed in clinical pathology.
2022-08
Tissuepathology.com
Mindpeak Announces CE-mark For New Product: Breast HER2 RoI
Mindpeak received CE-mark for its new product, Mindpeak Breast HER2 RoI, which assists pathologists in scoring digital images of HER2-stained breast cancer tissue, showing a significantly higher agreement rate compared to manual scoring.
2022-07
Medical Device Network
Mindpeak's breast cancer cell detection software receives CE-IVD mark
Mindpeak's AI-based software, BreastIHC, for identifying and quantifying breast cancer cells in primary diagnosis, received CE-IVD mark, making it available to pathologists in Europe.
2021-05

Videos

Product demos, reviews, and walkthroughs for Mindpeak Breast.

View all on YouTube

Frequently Asked Questions

Mindpeak Breast AI analyzes key breast cancer biomarkers such as HER2, ER, PR, and Ki-67. It is intended to assist pathologists in routine diagnostics by automating tissue analysis for faster, more accurate, and reproducible quantification of these markers, ultimately aiming to improve diagnostic speed and accuracy and support treatment decisions.
Mindpeak's AI algorithms are CE-IVD marked, signifying compliance with essential health and safety requirements for in-vitro diagnostic medical devices in Europe. The company also holds ISO 13485:2016 certification for its Quality Management System, demonstrating adherence to high international standards for safety, reliability, and compliance in the medical device industry. Mindpeak's solutions are designed to operate without cloud connectivity, offering data privacy and security for clinical and research environments.
While Mindpeak Breast AI aims to improve diagnostic accuracy and efficiency, general limitations in current AI use in breast cancer diagnosis include the need for extensive external and prospective validation, potential reliance on unimodal data sources, and challenges in model explainability. Mindpeak's Breast HER2 solution is currently intended for Research Use Only in some contexts, though a CE-IVD marked ROI variant is available in the EU, which could impact its immediate clinical applicability depending on the region.
Several other companies offer AI-powered digital pathology solutions for breast cancer diagnostics, including Paige.AI, Ibex Medical Analytics, Visiopharm, Indica Labs, and Aiforia. PathAI also offers a platform that integrates Mindpeak's algorithms, alongside solutions from Stratipath and Primaa, providing a comprehensive CE-IVD digital pathology ecosystem.
Mindpeak Breast AI is designed for seamless integration into existing digital pathology platforms and image management systems (IMS) like Pathomation's, Leica Biosystems' Aperio HALO AP, and Paige Platform. This allows pathologists to access AI-powered analysis directly within their routine diagnostic workflow, often as a '0-click solution' without complex setup or calibration.

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Suggest an Edit → | Last Verified: 2026-07-09 | First Added: 2026-07-09
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