AI Health Index
Digital Pathology AI
L

Lunit SCOPE

Lunit SCOPE is the pathology AI line of Lunit, the Seoul medical AI company. Drug companies, contract research organizations and digital pathology platforms use it to measure cancer biomarkers on tissue slides for research and trials. Lunit's radiology products have a separate record.

SCOPE IO reads a routine stained slide and classifies how immune cells are arranged around a tumor. In a 2022 study of 518 lung cancer patients in the Journal of Clinical Oncology, that pattern tracked response and survival on immunotherapy. The IHC suite scores PD-L1, HER2 and other stained markers, with cut offs set for a specific therapy. SCOPE GP predicts gene changes from a routine slide, to help pick which patients to send for molecular testing, and Lunit is codeveloping a lung cancer version with AstraZeneca.

Every SCOPE product is labeled for research use only. No price is published.

AI Health Index verifiedOctober 2, 2026
Compare Lunit SCOPE with other vendors
Founded
2013
Headquarters
Seoul, South Korea
Categories
pathology-ai, clinical-trials-ai
Indexed Products
Lunit SCOPE IO, Lunit SCOPE PD-L1, Lunit SCOPE HER2, Lunit SCOPE uIHC, Lunit SCOPE GP (Genotype Predictor)
Buyer Segments
Biopharma translational and companion diagnostic teams, Contract research organizations, Digital pathology platform providers, Pathologists (research use)
Assessment

Capability Axes

An AI Health Index grade measures what a buyer can verify from public sources on the date shown. It is not a rating of how good the product is. A vendor can build an excellent system and grade low on an axis because it publishes nothing an outsider can check. How grades read

AI Capability
AI Centrality
AA on AI CentralityThe artificial intelligence is the product. Remove the model and there is nothing left to sell.
Vendor Published

The models are the product. Every Lunit SCOPE product is an AI analysis of a pathology slide: immune patterns from tumor infiltrating lymphocytes, scoring of immunohistochemistry stains, and gene mutation and protein expression predicted from H&E. The SCOPE line sells no scanner, stain or laboratory service, so without the models there is nothing to deliver.

Ask which model version produced an analysis delivered for a study, and whether custom cut offs are tuned per program.

Autonomy and Oversight Model
BB on Autonomy and Oversight ModelThe oversight structure is described and one part is missing, commonly the threshold at which the system stops or what happens after it is wrong.
Vendor Published

Lunit describes the role of each output, and leaves open what happens after an error. SCOPE GP comes with models tuned either for high sensitivity or for high specificity, positioned for pre screening before molecular testing, so a confirming test follows the prediction. The IHC suite is described as helping pathologists, with custom scoring and cut offs for a therapy. All products are labeled research use only, not for diagnostic decisions.

Nothing published says how a pathologist reviews SCOPE scores, or what Lunit does when a delivered score or prediction proves wrong.

Ask for the operating points offered for SCOPE GP, how pathologists review IHC scores, and how errors in delivered analyses are corrected.

Model and Technology Transparency
BB on Model and Technology TransparencyThe approach or the suppliers are named without the version and update discipline behind them. Naming a supplier is the entry to this band both here and on Model Supply Chain Disclosure, which ask different questions of the same disclosure: who receives the data, and what produces the output.
Vendor Published

Lunit has published the approach for its lead product, without versions or update practice. The 2022 Journal of Clinical Oncology study describes how SCOPE IO finds tumor infiltrating lymphocytes and outlines tumor and supporting tissue to classify the immune pattern. The product pages describe what each IHC and genotype model measures, and the choice of models tuned for sensitivity or specificity.

No model versions, training data details or release notes are published for the SCOPE line.

Ask for the model version and training data behind each product, and how sponsors are told when a model changes during a study.

Model Supply Chain Disclosure
BB on Model Supply Chain DisclosureSubstantial partial disclosure, or a chain that is structurally short: an in house build, a cleared model that cannot be quietly swapped, or a deployment where the transfer does not occur at all. Naming the model provider exits the band below into this one; the axis rises from here on the completeness of the party list and on the terms that govern data once it arrives.
Vendor Published

Lunit builds the SCOPE models itself, so no outside model provider sits between a slide and a score. It names CellCarta and digital pathology platforms as delivery partners.

The hosting provider, the parties that process slides on each delivery route, and any subprocessor list are not published.

Ask which parties receive slides on each route, including platform partners and contract research organizations, and for the hosting provider.

Clinical and Operational Evidence
BB on Clinical and Operational EvidenceNamed deployments with dated outcome figures and enough method to test them, or published research short of independent validation.
Peer Reviewed Publication

Peer reviewed research led by the company supports SCOPE IO, short of independent validation of the products sold. A 2022 study in the Journal of Clinical Oncology (Park and colleagues, with Lunit authors, and Tony Mok of the Chinese University of Hong Kong as a joint senior author) classified 518 patients with non small cell lung cancer by the immune pattern SCOPE IO computes.

Patients with the inflamed pattern had higher response rates and longer progression free survival on checkpoint inhibitors, including those with PD-L1 tumor proportion scores of 1 to 49 percent. Progression free and overall survival differed across the three patterns. Lunit says its IHC and genotype models are validated across internal and external datasets, without setting out the figures on the product pages.

The study looked back at past patients and reports associations. None of the evidence is an independent evaluation of a SCOPE product as sold.

Ask for agreement with pathologists for the IHC suite, sensitivity and specificity at each SCOPE GP operating point, and any prospective use in a trial.

AI Safety and PHI Stewardship
CC on AI Safety and PHI StewardshipGeneral assurances of privacy and security that do not answer the questions artificial intelligence raises: what is retained, what reaches a model, and what happens to it there.
Vendor Published

Lunit gives security assurances for the company, without answers for the pathology line. It publishes an information security page with its ISO/IEC 27001 certification and a bug bounty program. Its radiology product pages say customer images are kept only for processing and not used for retraining.

Nothing published says whether the same holds for slides SCOPE analyzes, how long they are kept, or how training slides were sourced and de identified. No safety engineering for the SCOPE models is published.

Ask whether sponsor and laboratory slides are used to train SCOPE models, how long slides and outputs are kept, and how training data was de identified.

Regulatory and Compliance
HIPAA and BAA Posture
DD on HIPAA and BAA PostureNo statement of status and no privacy document that reaches the product. Both halves are absent at this grade: a service level privacy document on its own lifts a vendor to the band above even where no status is stated. A website privacy notice, including one that says it does not cover customer data, does not reach the product, so a vendor whose only document is that notice and who states no status grades here.
Vendor Published

Lunit states no business associate position, and its only published privacy document covers the website. Its privacy notice, effective October 2025, covers website visitors, marketing and events, job applicants and support contacts. It does not address slides or patient data analyzed by SCOPE products.

No business associate agreement or data processing agreement is published. Lunit's footer links a trust center hosted on TrustShare, whose contents load only in a browser.

Ask whether Lunit acts as a processor or business associate for slides analyzed for a study, and for the data processing terms with sponsors and contract research organizations.

Security Certifications and Trust Center
BB on Security Certifications and Trust CenterA recognized certification is named in the vendor own material without the artifact, or with a scope or renewal question the buyer has to raise. A recognized certification here is an audit of how the vendor operates security, such as SOC 2, HITRUST or ISO/IEC 27001. A certification has a scope and a clock, and both are part of this grade. A certification the vendor attaches to its data center, hosting facility or cloud provider, rather than presenting as its own, is the host's and does not count here.
Vendor Published

Lunit, the parent company, names a recognized certification without publishing it. Its information security page states that Lunit.io is certified to ISO/IEC 27001, and its manufacturing site holds ISO 13485:2016 and MDSAP certification. Lunit's footer links a trust center hosted on TrustShare, whose contents load only in a browser, and a bug bounty program.

The certificate, its scope and its date are not shown, and nothing says whether the scope covers SCOPE analysis services.

Ask for the ISO/IEC 27001 certificate and statement of applicability, and whether it covers SCOPE processing.

FDA and Regulatory Status
CC on FDA and Regulatory StatusNo device claim is made and the product is scoped accordingly. Most administrative and operational products sit here and are not penalized for it, because this axis grades the appropriateness of the positioning rather than possession of a clearance.
Vendor Published

Lunit makes no device claim for the current SCOPE products, and labels each for research. Its SCOPE pages state that SCOPE GP and the IHC suite (PD-L1, HER2 and uIHC) are for research use only, not for diagnostic procedures or decisions. Lunit cites ISO 13485, MDR and MDSAP compliance for its quality system.

Trade press reported a CE IVD mark for Lunit SCOPE PD-L1 TPS, but the current pages do not carry it. The FDA's databases list no SCOPE device. Lunit's FDA clearances are for its radiology products.

Ask whether any SCOPE product carries a CE IVD mark today, and for the regulatory plan for SCOPE GP as a companion pre screening tool.

AI Governance and Bias Disclosure
CC on AI Governance and Bias DisclosureResponsible artificial intelligence is committed to in policy language with no evaluation behind it. Most of the index sits here.
Vendor Published

Lunit asserts validation across datasets, but the SCOPE pages compare no results across groups. Lunit says its SCOPE models are validated across diverse internal and external datasets, lists publications, and has a certified quality system.

The product pages set out no results by scanner, stain, laboratory, tumor type or patient group. No evaluation or monitoring process specific to the pathology models is described.

Ask for results by scanner, laboratory and patient demographics for each SCOPE product, and how performance is monitored after model updates.

AI Liability and Recourse
CC on AI Liability and RecourseMechanisms exist that let someone challenge an output, such as audit trails, source traceability or review before commit, with nothing standing behind the output and no route for the harmed party.
Vendor Published

A confirming test is built into the intended use, but nothing stands behind the output. SCOPE GP is positioned as pre screening before molecular testing, so a confirming test can catch a wrong prediction, and the products are labeled research use only.

No error rate at a stated operating point, warranty, remedy or correction route for a SCOPE analysis is published.

Ask for false negative rates at the high sensitivity setting, and what Lunit commits to when a delivered analysis is found wrong.

Integration and Deployment
EHR and Interoperability Depth
CC on EHR and Interoperability DepthIntegration is claimed through standards or a middleware layer with no system named and nothing to verify.
Vendor Published

No clinical record integration exists, and research system integration is claimed without names. Lunit says SCOPE works with a wide range of scanners and image management systems, and deploys across digital pathology platforms and contract research partners, naming CellCarta.

The product pages name no scanner, image management system, file format or interface.

Ask which scanners, image management systems and slide formats SCOPE runs on in production, and how results reach a sponsor's systems.

Deployment Model and Data Residency
CC on Deployment Model and Data ResidencyA single hosted option with location implied rather than committed.
Vendor Published

SCOPE reaches buyers through partners, and where it runs is implied, not stated. Lunit describes SCOPE as deployable across digital pathology platforms and contract research partners, and runs analyses for drug company programs.

Nothing published says where slides are processed or stored, which cloud is used, whether processing happens in Korea, or whether SCOPE can run on premises.

Ask where slides are processed and stored, whether any data leaves the sponsor's region, and whether SCOPE can run inside a sponsor's or laboratory's environment.

Commercial
Commercial Transparency
CC on Commercial TransparencyNo price is published and the posture is discoverable: a buyer can establish how the product is sold and what drives the cost before contacting the vendor. Most of the index sits here.
Vendor Published

No price is published, but how the products are sold can be worked out. Lunit sells the SCOPE line to drug companies, contract research organizations and digital pathology platform providers. It sells through codevelopment, such as the AstraZeneca lung cancer pre screening tool, and through partners such as CellCarta, with custom scoring and cut offs built for specific therapies.

No license basis, per slide or per study price is published.

Ask whether SCOPE is priced per slide, per study or by license, and how codevelopment programs are structured.

Setting and Specialty Coverage
BB on Setting and Specialty CoverageCoverage is named with validation behind part of it.
Vendor Published

Lunit names coverage product by product, with peer reviewed validation behind part of it. SCOPE IO classifies the immune pattern on H&E slides and is validated in non small cell lung cancer, in the 2022 study of 518 patients. The IHC suite covers PD-L1, HER2 and a universal analyzer for other immunohistochemistry markers. SCOPE GP predicts lung cancer driver alterations from H&E. All are research use only.

Lunit sells the line to drug companies and contract research organizations for biomarker work tied to specific therapies and for trial pre screening, which is why it is also listed under clinical trials.

Ask which tumor types and markers each product is validated for, and on which scanners.

Commercial

Pricing

Vendor-published figures are labeled as such. Figures labeled “Estimated” are derived from third-party sources and have not been confirmed by the vendor.

Entry Price Pricing Basis BAA Tier Implementation Source
Not published
 Research use AI analysis for biopharma, contract research organizations and pathology platforms, through direct programs, codevelopment and partners; no unit of charge or price published. Not published. Lunit's privacy notice covers its websites and contacts; no business associate or data processing agreement is published. Not published. Vendor Published

Lunit sells the SCOPE line to biopharma and contract research organizations, including through codevelopment such as the AstraZeneca lung cancer pre screening tool and the CellCarta alliance, with custom scoring and cut offs per therapy, and publishes no price, unit of charge or license term. A buyer should ask whether analyses are priced per slide, per study or by license.