Lunit SCOPE HER2

Lunit SCOPE HER2 is an AI-assisted software tool designed for HER2 immunohistochemistry (IHC) expression quantification, built for biopharma companies, research teams, and pathology workflows focused on oncology biomarker analysis. By combining advanced image analysis with proven AI capabilities, it improves the speed, accuracy, and sensitivity of HER2 IHC scoring — including the detection of ultralow HER2 signals that are frequently missed during manual review.

The platform is intended for research use and is positioned as a core component of end-to-end companion diagnostic (CDx) development, supporting biopharma innovation across biomarker strategy, clinical trial optimization, and oncology R&D at scale.

Key Capabilities

• Ultralow HER2 signal detection: Lunit SCOPE HER2 can uncover up to 24% more HER2 ultralow signals, including cases previously categorized as HER2-negative. A retrospective study demonstrated that AI-powered analysis identified 23.6% of whole slide images (WSIs) initially scored as HER2-negative by pathologists as HER2 ultralow.
• Improved scoring agreement: The software enhances reading consistency and accuracy through objective, reliable HER2 analysis. Published clinical evidence shows that pathologist concordance improved by 20% after revisiting cases with AI-assisted scoring.
• Enhanced productivity: Lunit SCOPE HER2 shortens reading time for HER2 IHC scoring, enabling pathologists and research teams to process cases more efficiently without sacrificing analytical depth.

Clinical and Research Evidence

• A retrospective study supports the platform's ability to surface HER2 ultralow signals missed in standard pathologist review, with findings published in peer-reviewed literature.
• Lunit AI has been featured in studies examining HER2-targeted therapy outcomes in metastatic colorectal cancer, published in JCO Precision Oncology.
• Research presented at AACR 2024 highlighted AI innovations in HER2 expression-mutation analysis and CNTN4 biomarker identification.
• An exploratory analysis of the Phase II TRIUMPH trial examined AI-powered HER2 and tumor microenvironment (TME) analysis in HER2-amplified metastatic colorectal cancer.

Biopharma and CDx Development Support

• Designed to help biopharma companies scale oncology R&D and advance biomarker strategies.
• Supports end-to-end CDx development with mature regulatory capabilities.
• Compatible with a broad range of scanners and file types, enabling flexible integration across digital pathology platforms.
• Scalable deployment is available through CRO partners and digital pathology platform providers.
• Deep expertise and established partnerships with multiple CROs and image management system (IMS) providers differentiate Lunit as a collaborative partner in AI-powered image analysis.

Related Solutions in the Lunit SCOPE Portfolio

• Lunit SCOPE PD-L1: AI-driven quantification for streamlined PD-L1 TPS scoring.
• Lunit SCOPE uIHC: IHC-based biomarker development and clinical trial enrichment.
• Lunit SCOPE IO: AI-powered immune phenotyping for tumor microenvironment insights.
• Lunit SCOPE GP: AI-powered genotype prediction for screening and discovery.

Lunit SCOPE HER2 is intended for research use only and is not approved for use in diagnostic procedures or clinical decisions. The platform's broad scanner compatibility, scalable deployment options, and growing body of clinical evidence make it a robust solution for teams seeking to integrate AI into their HER2 biomarker research and drug development workflows.