Lunit SCOPE PD-L1

JSON twin: https://www.healthaidb.com/software/lunit-scope-pd-l1.json

Company Name

Lunit

Product URL

https://www.lunit.io/en/products/pdl1

Company URL

https://www.lunit.io

Categories

• diagnostic Support
• clinical Care
• oncology Care
• pathology
• ai Clinical Documentation Integrity
• clinical Decision Support
• Diagnostic
• Clinical
• Oncology
• Artificial Intelligence

Summary

Lunit SCOPE PD-L1 is an AI-powered solution that analyzes PD-L1 expression in non-small cell lung cancer (NSCLC) tissue samples to assist pathologists in assessing tumor proportion scores (TPS) for immunotherapy decisions.

Description

Lunit SCOPE PD-L1 utilizes artificial intelligence to detect and quantify PD-L1 expression in NSCLC tissue samples, providing tumor proportion scores (TPS) and combined positive scores (CPS) to support pathologists in immunotherapy decision-making. The solution has been integrated into platforms like Guardant360 TissueNext and Roche's navify® Digital Pathology, enhancing biomarker detection and analysis. It received the CE-IVD Mark in April 2022, indicating its compliance with European Union regulations for in vitro diagnostic devices. Lunit SCOPE PD-L1 is intended for research use only and is not cleared or approved by the U.S. Food and Drug Administration (FDA).

Api Available

yes

Certifications

• CE-IVDD Mark
• ISO 13485:2016
• ISO/IEC 27001
• MDSAP

Company Founding

2013

Company Offices

• South Korea
• United States
• Netherlands
• China

Compliance

• CE-IVDD Mark
• ISO 13485:2016
• ISO/IEC 27001
• MDSAP
• GDPR
• HIPAA

Customers

Data Residency

EU-only, US/EU regions, BYO cloud region

Data Standards

• DICOM
• HL7 v2
• FHIR
• SNOMED CT
• ICD-10

Deployment Model

• on_prem
• cloud
• hybrid

Features

• AI-based detection and quantification of PD-L1 expression in NSCLC tissue
• Automated identification of PD-L1 positive and negative tumor cells
• Calculation of Tumor Proportion Score (TPS) and Combined Positive Score (CPS)
• Visualization of PD-L1 expression through heatmaps and cutoff maps
• Integration with digital pathology platforms like Aperio HALO AP and Roche's navify Digital Pathology
• Enhanced accuracy and consistency in PD-L1 scoring compared to manual methods
• Reduction of inter-observer variability in PD-L1 assessment
• Support for research use in clinical trials and diagnostics

Id

SW2559

Integration Partners

Integrations

• Aperio HALO AP
• Roche navify Digital Pathology
• Guardant360 TissueNext PD-L1 test

Languages Supported

• English
• Korean
• Chinese
• Japanese
• Dutch

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

Os Platforms

• Web

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• Data anonymization
• Data minimization
• Compliance with GDPR and HIPAA regulations

Product Code

SW2559

Product Name

Lunit SCOPE PD-L1

Ratings

Regions Available

• Europe
• United States
• South Korea
• Japan
• China
• Canada
• United Kingdom

Related Urls

Release Year

Security Features

• Encryption (in transit and at rest)
• Role-Based Access Control (RBAC)
• Audit logs
• Data Loss Prevention (DLP)

Specialties

• Oncology
• Pulmonology
• Pathology

Support Channels

System Requirements

Compatible with Leica, Philips, 3D Histech, Hamamatsu scanners at x40 magnification; requires integration with Leica image management system

Target Users

• pathologists
• oncologists
• clinical researchers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "Lunit SCOPE PD-L1",
  "company_name": "Lunit",
  "product_url": "https://www.lunit.io/en/products/pdl1",
  "company_url": "https://www.lunit.io",
  "related_urls": [],
  "product_code": "SW2559",
  "summary": "Lunit SCOPE PD-L1 is an AI-powered solution that analyzes PD-L1 expression in non-small cell lung cancer (NSCLC) tissue samples to assist pathologists in assessing tumor proportion scores (TPS) for immunotherapy decisions.",
  "description": "Lunit SCOPE PD-L1 utilizes artificial intelligence to detect and quantify PD-L1 expression in NSCLC tissue samples, providing tumor proportion scores (TPS) and combined positive scores (CPS) to support pathologists in immunotherapy decision-making. The solution has been integrated into platforms like Guardant360 TissueNext and Roche's navify® Digital Pathology, enhancing biomarker detection and analysis. It received the CE-IVD Mark in April 2022, indicating its compliance with European Union regulations for in vitro diagnostic devices. Lunit SCOPE PD-L1 is intended for research use only and is not cleared or approved by the U.S. Food and Drug Administration (FDA).",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "oncology Care",
    "pathology",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "Diagnostic",
    "Clinical",
    "Oncology",
    "Pathology",
    "Artificial Intelligence"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "pathologists",
    "oncologists",
    "clinical researchers"
  ],
  "specialties": [
    "Oncology",
    "Pulmonology",
    "Pathology"
  ],
  "regions_available": [
    "Europe",
    "United States",
    "South Korea",
    "Japan",
    "China",
    "Canada",
    "United Kingdom"
  ],
  "languages_supported": [
    "English",
    "Korean",
    "Chinese",
    "Japanese",
    "Dutch"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "South Korea",
    "United States",
    "Netherlands",
    "China"
  ],
  "company_founding": "2013",
  "deployment_model": [
    "on_prem",
    "cloud",
    "hybrid"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "AI-based detection and quantification of PD-L1 expression in NSCLC tissue",
    "Automated identification of PD-L1 positive and negative tumor cells",
    "Calculation of Tumor Proportion Score (TPS) and Combined Positive Score (CPS)",
    "Visualization of PD-L1 expression through heatmaps and cutoff maps",
    "Integration with digital pathology platforms like Aperio HALO AP and Roche's navify Digital Pathology",
    "Enhanced accuracy and consistency in PD-L1 scoring compared to manual methods",
    "Reduction of inter-observer variability in PD-L1 assessment",
    "Support for research use in clinical trials and diagnostics"
  ],
  "optional_modules": [],
  "integrations": [
    "Aperio HALO AP",
    "Roche navify Digital Pathology",
    "Guardant360 TissueNext PD-L1 test"
  ],
  "data_standards": [
    "DICOM",
    "HL7 v2",
    "FHIR",
    "SNOMED CT",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": "Compatible with Leica, Philips, 3D Histech, Hamamatsu scanners at x40 magnification; requires integration with Leica image management system",
  "compliance": [
    "CE-IVDD Mark",
    "ISO 13485:2016",
    "ISO/IEC 27001",
    "MDSAP",
    "GDPR",
    "HIPAA"
  ],
  "certifications": [
    "CE-IVDD Mark",
    "ISO 13485:2016",
    "ISO/IEC 27001",
    "MDSAP"
  ],
  "security_features": [
    "Encryption (in transit and at rest)",
    "Role-Based Access Control (RBAC)",
    "Audit logs",
    "Data Loss Prevention (DLP)"
  ],
  "privacy_features": [
    "Data anonymization",
    "Data minimization",
    "Compliance with GDPR and HIPAA regulations"
  ],
  "data_residency": "EU-only, US/EU regions, BYO cloud region",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW2559",
  "slug": "lunit-scope-pd-l1",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/lunit-scope-pd-l1.json"
  }
}