Lunit - AI-powered cancer detection and precision oncology platform

What is Lunit

If you work in healthcare, you've likely witnessed the growing pressure on radiologists and pathologists. Patient volumes are increasing, but the number of specialists isn't keeping pace. Early cancer detection remains a challenge—especially for conditions like breast cancer and tuberculosis where timely intervention dramatically improves outcomes. This is exactly the problem Lunit was built to solve.

Lunit is a medical AI company specializing in early cancer detection and precision oncology. Founded in 2013 as CLDI and rebranded to Lunit in 2018, the company went public on KOSDAQ in 2021 (stock code: 328130). What sets Lunit apart is its comprehensive AI ecosystem that spans the entire cancer care continuum—from screening and diagnosis to treatment guidance.

The platform serves over 10,000 medical sites across 65+ countries, supported by a network of 100+ partners including industry leaders like Microsoft, AstraZeneca, GE Healthcare, Philips, and Roche. Lunit's technology is backed by rigorous scientific validation, with 700+ peer-reviewed academic publications in top journals including JAMA Oncology, Radiology, and The Lancet Digital Health.

When it comes to regulatory compliance, Lunit leads the industry. Its products carry FDA clearance, CE-MDR certification, and PMDA approval (Japan). The Lunit INSIGHT CXR solution is even recommended by the World Health Organization (WHO) for tuberculosis screening— a rare distinction that speaks to the platform's clinical reliability.

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Lunit's Core Products and Capabilities

Lunit offers two integrated product lines: Lunit INSIGHT for radiology imaging AI, and Lunit SCOPE for precision oncology and pathology analysis. Together, they provide a complete workflow solution for healthcare providers and biopharmaceutical companies.

Lunit INSIGHT Radiology AI

Lunit INSIGHT MMG is an AI-powered 2D mammography solution designed to improve breast cancer detection accuracy. It automatically annotates suspicious areas with 96-99% accuracy, helping radiologists identify cancers earlier while reducing recall rates—a critical capability given that false positives create unnecessary anxiety and healthcare costs.

Lunit INSIGHT DBT addresses 3D breast tomosynthesis imaging, which offers clearer views of dense breast tissue but generates hundreds of slices per study. Lunit's Best-slice selection technology intelligently highlights the most clinically relevant images, reducing reader fatigue without compromising diagnostic quality. This product holds CE-MDR certification.

Lunit INSIGHT CXR is perhaps the most versatile product in the portfolio. It detects 11 major thoracic abnormalities from chest X-rays, including pneumonia, pneumothorax, and tuberculosis. The DualScan architecture enhances specificity, reducing false positives that could overwhelm radiologists. This solution is FDA cleared, CE-MDR certified, and WHO-recommended for tuberculosis screening programs—making it a go-to choice for public health initiatives worldwide.

Lunit SCOPE Precision Oncology

For pathology and biopharmaceutical research, Lunit SCOPE provides AI-powered tissue analysis:

• Lunit SCOPE IO analyzes the tumor microenvironment (TME) from H&E images, enabling AI-driven immune phenotype characterization. This supports immunotherapy response prediction and biomarker discovery.
• Lunit SCOPE IHC Suite provides quantitative analysis for immunohistochemistry (IHC) markers including uIHC, HER2, and PD-L1. These tools accelerate clinical trial workflows and companion diagnostic development.
• Lunit SCOPE GP predicts genetic mutations directly from H&E slides—offering a rapid, cost-effective alternative to expensive genomic testing for initial screening.

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Who Is Using Lunit

Lunit's solutions serve a diverse range of healthcare organizations, from large hospital networks to specialized clinics and biopharmaceutical companies. Here's how different users benefit:

Large Hospital Networks and Screening Centers

If you manage a high-volume breast cancer screening program, you know how challenging it is to maintain consistent accuracy across thousands of mammograms. Lunit INSIGHT MMG and DBT automatically flag suspicious findings, helping your radiologists catch cancers they might otherwise miss—especially in dense breast tissue where traditional 2D mammography has known limitations. Early detection translates directly to better outcomes and lower treatment costs.

Public Health Organizations and TB Programs

For organizations running tuberculosis screening initiatives, particularly in resource-limited settings, Lunit INSIGHT CXR offers a powerful triage tool. The AI can process chest X-rays in seconds, prioritizing cases that need immediate attention while flagging normal studies. This is particularly valuable in areas with critical radiologist shortages. The WHO endorsement further validates its suitability for population-level screening programs.

Radiology Departments Seeking Quality Improvement

If you're responsible for radiology quality assurance, Volpara Analytics and Volpara Live provide real-time monitoring of imaging quality and technologist performance. These tools help reduce repeat exposure rates, improve positioning consistency, and create measurable quality benchmarks—critical for accreditation and continuous improvement initiatives.

Breast Centers需要标准化密度评估

乳腺密度评估长期存在主观性问题。Volpara Scorecard 自动分析乳腺密度，提供一致、客观的报告，而 Volpara Risk Pathways 利用 AI 驱动风险建模，帮助您识别高风险患者并制定个性化筛查计划。

生物制药公司进行精准肿瘤学研究

如果您在生物制药行业工作，Lunit SCOPE 产品线可以加速您的生物标志物发现和临床试验患者筛选流程。免疫肿瘤学分析和 IHC 定量与 Guardant Health 等合作伙伴的分子数据集成，使您能够更高效地识别可能受益于特定治疗的患者。

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Technical Features and Clinical Validation

What makes Lunit's AI technology reliable enough for clinical use? The answer lies in rigorous technical architecture, extensive training data, and uncompromising validation standards.

Technical Foundation

Lunit's AI models are built on deep learning architectures trained on millions of high-quality, expert-annotated medical images. The training data comes from global clinical partnerships, ensuring diverse patient populations and varied imaging equipment. This diversity is critical—AI models that perform well on one dataset often struggle in real-world settings with different equipment, patient demographics, or clinical workflows.

The platform employs multi-modal AI that integrates imaging data with clinical and molecular information. For precision oncology applications, this means combining histopathology images with patient records and genomic data to generate richer, more actionable insights.

Performance Metrics

Lunit consistently achieves 96-99% accuracy across its core applications, though performance varies by use case and clinical setting. The DualScan architecture in Lunit INSIGHT CXR is particularly notable—it improves specificity without compromising sensitivity, reducing the false positive rate that contributes to radiologist burnout and unnecessary follow-up procedures.

Regulatory and Compliance

Lunit maintains one of the strongest regulatory portfolios in the medical AI space:

• FDA clearance: Lunit INSIGHT MMG and CXR Triage
• CE-MDR certification: Multiple products including INSIGHT DBT and CXR
• PMDA approval: Japan market authorization
• WHO recommendation: INSIGHT CXR for TB screening programs

All INSIGHT solutions integrate seamlessly with existing hospital systems through PACS and RIS compatibility, supporting standard DICOM formats. This ensures quick, secure deployment with minimal workflow disruption.

Clinical Evidence

With 700+ peer-reviewed publications, Lunit's technology has been extensively validated in real-world clinical settings. Studies published in JAMA Oncology, Radiology, The Lancet Digital Health, and other leading journals demonstrate consistent performance across different populations and healthcare contexts.

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Pricing and Solutions

Lunit operates on a B2B enterprise model, and pricing is not publicly available on the website. This is common for medical software solutions where costs depend heavily on specific institutional needs.

What Affects Pricing

Several factors influence the total cost of ownership:

• Institution size: Number of sites, users, and annual imaging volume
• Product selection: Which INSIGHT modules you deploy (MMG, DBT, CXR, or combinations)
• Deployment model: Cloud-based or on-premises installation
• Support level: Basic versus premium support packages
• Integration requirements: Extent of PACS/RIS customization needed

Product Line Overview

Important Notes

• Lunit SCOPE products are designated Research Use Only (RUO) and are not intended for clinical diagnosis or treatment decisions. They are designed for biopharmaceutical research and biomarker discovery workflows.
• Volpara products (acquired by Lunit in 2023) form a comprehensive breast health management suite, ideal for organizations looking to standardize density reporting and risk-based screening protocols.
• A concept proof (POC) is typically available for qualified institutions—contact the sales team to discuss your specific needs.

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Common Questions