Lunit SCOPE IO

Lunit SCOPE IO® is an AI-powered tumor microenvironment (TME) analysis software designed for biopharma companies seeking to identify and develop immune biomarkers from H&E-stained whole-slide images. Built for research use in oncology drug development, the platform enables quantitative immune phenotyping, spatial analysis, and companion diagnostic (CDx) development without requiring additional stains or assays.

Trained on more than 50,000 whole-slide images and over 10 million cell annotations contributed by hundreds of pathologists worldwide, Lunit SCOPE IO has been tested on 2,300+ real-world patient samples, with findings published in leading journals including JCO and JITC. The platform is tumor-agnostic, supporting broad application across diverse cancer types and drug development programs.

Core Analytical Capabilities

• Quantitative immune phenotyping of the tumor microenvironment from standard H&E slides
• Extraction of key morphological features including tertiary lymphoid structures (TLS), necrosis, mitosis, tumor-stroma ratio, and spatial patterns at tumor-stroma borders
• Cell-level identification and classification of tumor cells, lymphocytes, macrophages, fibroblasts, and endothelial cells
• Analysis of tumor-infiltrating lymphocytes (TILs) and classification of immune phenotypes: Inflamed, Excluded, and Desert
• Spatial and cell-level morphology analysis to enable deeper understanding of TME biology and candidate biomarker signals

Biomarker Discovery and CDx Development

• Supports identification of tumor-agnostic, H&E-based immune biomarkers with precision and at scale
• Accelerates biomarker development and enriches immunotherapy trials without the need for additional staining or assays
• CDx-ready AI software applicable across the full clinical pathway, from early-stage biomarker discovery through to predicting patient response to immunotherapies
• Supports patient selection and stratification strategies in clinical trials
• Demonstrated in a case study quantifying how TME cellular composition correlates with response to atezolizumab, showing potential for patient stratification and treatment selection

Clinical and Research Evidence

• Validated on 2,300+ real-world patient samples with results published in JCO and JITC
• Research presented at major oncology conferences including SITC 2023, covering AI-powered TME analysis predicting treatment outcomes in NSCLC patients with EGFR mutations
• Published work includes AI-powered spatial profiling of MET-mutated non-small cell lung cancer identifying immune-active MET exon 14 skipping subtypes as potential immunotherapy targets

Platform and Deployment

• Built for end-to-end CDx development with mature regulatory capabilities
• Compatible with a broad range of scanners and image management systems (IMS) and file types
• Scalable deployment across digital pathology platforms and CRO partners
• Global alliance with CellCarta to expand access to digital pathology AI for clinical trials
• Deep expertise and partnerships with multiple CROs and digital pathology platform providers

Lunit SCOPE IO is intended for research use only and is not for use in diagnostic procedures or decisions. It is part of Lunit's broader suite of AI pathology solutions, which also includes tools for IHC-based biomarker development, genotype prediction, HER2 expression analysis, and PD-L1 TPS scoring.