Digital pathology
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Last updated: June 5, 2026
Back to directoryLunit SCOPE medical AI product profile
Digital pathology AI suite from Lunit for precision-oncology research, biomarker discovery, IHC analysis, and selected pathologist-assistive workflows.
Digital pathology
Best fit
Teams evaluating AI pathology analysis for oncology biomarker programs, immunotherapy research, trial enrichment, or governed pathology AI pilots with module-specific intended-use review.
- Primary use case
- AI-powered digital pathology analysis for tumor microenvironment profiling, IHC quantification, PD-L1 scoring support, genotype prediction research, and biomarker development workflows
- Audience
- Pathology labs, biopharma translational teams, companion-diagnostic groups, oncology research teams, and digital pathology governance committees
- Risk level
- High
- Pricing signal
- Enterprise, research, and partnership pricing is not public; verify current module, integration, scanner, study, and regional commercial terms.
- Official sources
- 6 official sources
Compare within workflow: Digital pathology · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Lunit SCOPE as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Separate every SCOPE module, version, geography, study purpose, and intended use before deployment; research-use-only language on SCOPE IO, GP, uIHC, and IHC Suite pages should not be treated as diagnostic authorization. |
|---|---|
| Privacy | Review whole-slide image transfer, platform integrations, support access, annotations, study metadata, product-service data, de-identified data handling, retention, international transfers, and customer-contract privacy terms. |
| Evidence | Use Lunit's publication library, module-specific validation materials, and local pilot data to test scanner mix, tissue and stain quality, cancer subtype, biomarker endpoint, reproducibility, pathologist agreement, and trial-readout impact. |
| Workflow | Best governed as a module-specific digital pathology and biopharma analysis workflow with pathologist, translational science, clinical-trial, privacy, and regulatory review before outputs inform patient selection or reports. |
Where Lunit SCOPE fits
Lunit describes SCOPE as a precision-oncology digital pathology suite for H&E tumor microenvironment analysis, IHC biomarker strategy, genotype prediction, and PD-L1 quantification; its product pages label several SCOPE workflows as research use only and not for diagnostic procedures or decisions, while Lunit's publications and privacy materials provide evidence and data-handling context to verify before clinical or trial adoption.
Not for: Autonomous diagnosis, treatment selection, assuming all SCOPE modules are cleared for clinical use, or using research-use modules in diagnostic procedures or decisions.
What to verify before using Lunit SCOPE
- Which module is in scope: SCOPE IO, IHC Suite, uIHC, HER2, PD-L1, GP, or another Lunit precision-oncology product.
- Whether the selected module is research use only, CE-marked, commercialized in the deployment market, or otherwise authorized for the intended diagnostic, trial, or biopharma workflow.
- Scanner, image-management-system, CRO, digital pathology platform, report, study, tissue, stain, cancer type, and companion-diagnostic integration requirements.
- How whole-slide images, annotations, study metadata, patient identifiers, support access, retention, secondary-use rights, and international transfers are handled under the customer agreement.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.lunit.io / en / precision-oncology
- www.lunit.io / en / precision-oncology
- www.lunit.io / en / precision-oncology
- www.lunit.io / en / products
- www.lunit.io / en / publications
- www.lunit.io / en / privacy-policy
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