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TEST:
Lunit SCOPE PD-L1

Company:
Lunit
Type:
CE Marked
Related tests:
Evidence

News

3ms
Lunit to present AI-driven cancer treatment study at SITC 2024, selected for rapid oral presentation (Lunit Press Release)
"Lunit said...that it would present one of the latest studies using its AI biomarker platform, Lunit Scope, at the Society for Immunotherapy of Cancer 2024 (SITC 2024) in Houston, Texas, from Nov. 6 to 10...Lunit will present a study on AI-enabled immuno-oncology treatment response prediction in patients with various cancer types, including rare cancers."
Clinical data
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Lunit SCOPE HER2 • Lunit SCOPE IO • Lunit SCOPE PD-L1
4ms
Lunit to Present AI-Analyzed Immune Phenotype Study as Immunotherapy Response Predictor for Advanced Gastric Cancer at ESMO Congress 2024 (PRNewswire)
"Lunit...announced the presentation of a significant study at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, from September 13-17...The study analyzed H&E images from 585 AGC patients, with Lunit SCOPE IO classifying tumors into two immune phenotypes—inflamed (IIP) and non-inflamed—based on the presence and distribution of tumor-infiltrating lymphocytes (TILs) from hematoxylin and eosin (H&E) slides that are readily available from a standard clinical workup...Key findings include: Patients treated with Nivolumab+Chemotherapy showed significantly longer median progression-free survival (mPFS) compared to Chemotherapy alone (8.2 vs. 5.9 months); The inflamed immune phenotype group, classified by Lunit SCOPE IO, was associated with more pronounced PFS benefits from Nivolumab+Chemotherapy:"
Real-world evidence
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Lunit SCOPE PD-L1
|
Opdivo (nivolumab)
4ms
Lunit Joins Roche’s Digital Pathology Open Environment to Advance Cancer Biomarker Testing (PRNewswire)
"Lunit...announced its collaboration with Roche to integrate Lunit SCOPE PD-L1 22C3 TPS into Roche's navify Digital Pathology platform. This marks the first deployment of Lunit's AI technology with Roche, supporting pathologists and scientists with enhanced tools for cancer research as part of Roche's initiative to create a collaborative digital pathology ecosystem....The collaboration spans significant global territories, starting with the US, with future expansion targeted for Canada, the EU (UK), Korea, and Japan, underscoring the strategic intent to enhance cancer diagnostics and treatment across diverse healthcare markets. Lunit SCOPE PD-L1 22C3 TPS is an AI-powered tool that provides high-value insights and analysis of the PD-L1 tumor proportion score (TPS), a critical biomarker in cancer immunotherapy."
Licensing / partnership
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Lunit SCOPE PD-L1
1year
Artificial intelligence (AI)-powered immune phenotyping based on programmed death ligand 1 (PD-L1) immunohistochemistry (IHC) in triple negative breast cancer (TNBC) (SITC 2023)
Moreover, high PD-L1 expression of each respective cell type of tumor, lymphocyte, and macrophage was observed in the IIP. Consistent with previous knowledge of the IP, our PD-L1 results support use of immune-oncology approaches in this phenotype.
PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
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PD-L1 expression • PD-L1 overexpression
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PD-L1 IHC 22C3 pharmDx • Lunit SCOPE IO • Lunit SCOPE PD-L1
over1year
An Automated Clinical Workflow Integrating an AI-Driven PD-L1 22C3 Scoring Algorithm Into a Browser-Based Digital Pathology Solution (CAP 2023)
Automated clinical workflows integrating AI algorithms with IMS and LIMS can be used in clinical practice to simplify and strengthen pathology workflows. He is a shareholder of Gardant Health, Inc.
Clinical
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PD-L1 (Programmed death ligand 1)
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PD-L1 IHC 22C3 pharmDx • Lunit SCOPE PD-L1
over1year
Indica Labs and Lunit announce a strategic alliance for seamless integrated digital pathology AI workflows (Lunit Press Release)
"Indica Labs...and Lunit...announced an agreement to provide a fully interoperable solution between Indica Labs’ HALO AP® image management software platform and Lunit’s suite of AI pathology products...Lunit SCOPE PD-L1 NSCLC can be activated in the HALO AP user interface. Analysis progress, all results and visual markup images can be reviewed in HALO AP, so users never have to leave the viewer or shift between systems."
Licensing / partnership
|
Lunit SCOPE PD-L1
over1year
Effect of an artificial intelligence–powered programmed death-ligand 1 combined positive score analyzer in urothelial cancer on inter-observer and inter-site variability. (ASCO 2023)
This study shows that an AI-powered PD-L1 CPS analyzer in UC can reduce inter-observer and inter-site variability. This result suggests that the AI model will help evaluate CPS in UC more accurately and reduce variation in situations where pathologists analyze WSIs from unfamiliar institutions. >
PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Lunit SCOPE PD-L1
over1year
Performance validation of an artificial intelligence-powered PD-L1 combined positive score analyzer in six cancer types. (ASCO 2023)
This study shows that an AI-powered PD-L1 CPS analyzer can evaluate the CPS in the six cancer types analyzed here at a comparable level to pathologists. AI assistance can improve the concordance of pathologists' CPS interpretation. >
PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Lunit SCOPE PD-L1
almost2years
Lunit wins 'CLIA certification' from Guardant Health (Korea Biomedical Review)
"Lunit said it has completed validation of Lunit Scope PD-L1, its artificial intelligence pathology analysis solution, in Clinical Laboratory Improvement Amendments (CLIA)'s laboratory-developed test (LDT)...The company conducted the test at Guardant Health's CLIA Lab."
Regulatory
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Lunit SCOPE PD-L1
over2years
Lunit to Showcase 5 Abstracts at ESMO 2022 (PRNewswire)
"Lunit will also present clinical findings that demonstrate the accuracy of Lunit SCOPE PD-L1 CPS. After classifying PD-L1 Combined Positive Score (CPS) levels in 543 urothelial carcinoma (UC) cases, the AI-powered CPS analyzer showed an equivalent level of accuracy to that of pathologists....Another study from Lunit reveals the capability of the AI-powered TIL and PD-L1 CPS analysis solution to be utilized as a predictive biomarker for immune checkpoint inhibitor (ICI) response in neuroendocrine neoplasms (NEN)....The last study shows that Lunit SCOPE can discover novel targets for antibody-drug conjugates (ADC) by precisely analyzing linked NGS and IHC data in tumors, highlighting the potential of multimodal analysis linking molecular and visual methods."
Clinical data
|
Lunit SCOPE HER2 • Lunit SCOPE PD-L1
over2years
Performance validation of an artificial intelligence-powered programmed death-ligand 1 (PD-L1) combined positive score analyzer in urothelial cancer (ESMO 2022)
The performance of the AI model was similar with each individual pathologist (accuracy / ICC; 85.1% / 0.94, 86.6% / 0.90, and 87.1% / 0.93, respectively) and individual hospital dataset (accuracy / ICC; 89.4% / 0.92, 87.8% / 0.95, and 89.2% / 0.92, respectively). Table: 94P Conclusions This study demonstrates that an AI-powered PD-L1 CPS analyzer can classify CPS levels in UC comparable to pathologists.
PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Lunit SCOPE PD-L1
over2years
New studies at ASCO 2022 validate effectiveness of Lunit AI as diagnostic aid in cancer treatment (Lunit Press Release)
"New findings demonstrate the clinical efficacy of AI-powered tissue analysis as a guide in cancer treatment, according to medical AI provider Lunit. The findings will be presented at the 2022 ASCO Annual Meeting, to be held from June 3 to 7...One of the poster presentations by Lunit elaborates on the validation of the Inflamed Immune Phenotype (IIP) as a practical biomarker to guide immune checkpoint inhibitor (ICI) treatment. The IIP is assessed by Lunit SCOPE IO, Lunit’s AI-powered immune phenotype analyzer, from H&E slide images...Lunit will also deliver a presentation on Lunit SCOPE PD-L1 TPS, the company’s AI-powered PD-L1 tumor proportion score (TPS) analyzer."
Clinical data
|
Lunit SCOPE IO • Lunit SCOPE PD-L1
over2years
Lunit AI biomarker PD-L1 demonstrates clinical efficacy as diagnostic aid in cancer treatment–published in the European Journal of Cancer (Lunit Press Release)
"A recent study revealed that with the assistance of AI, multiple pathologists showed improved consensus in analyzing PD-L1 tumor proportion scores, finding more patients eligible for immunotherapy. The study has been published on May 14 in the European Journal of Cancer (EJC)...Findings from the study demonstrate the clinical efficacy of Lunit SCOPE PD-L1, the company’s AI-powered programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) analyzer, which recently received the CE mark for commercial use in the European market."
Clinical data
|
Lunit SCOPE PD-L1
over2years
Lunit AI solution for PD-L1 expression analysis receives CE mark (Lunit Press Release)
"Lunit...announced it has received the CE-IVDD Mark for ‘Lunit SCOPE PD-L1 TPS’, an AI-based PD-L1 tumor proportion score (TPS) analyzer...Lunit SCOPE PD-L1 is an AI solution that performs PD-L1 TPS classification that enhances objective and accurate analysis compared to traditional method...Lunit is working on launching Lunit SCOPE PD-L1 in Europe within the second half of 2022, paving the way for deployment and use in European pathology practices."
European regulatory
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Lunit SCOPE PD-L1
over2years
Lunit to Present 11 Abstracts at the 2022 ASCO Annual Meeting (Lunit Press Release)
"Lunit today announced the presentation of 11 abstracts featuring its AI-biomarker platform at the 2022 ASCO Annual Meeting from June 3 to 7....Findings from the study validate the effectiveness of Lunit SCOPE IO—Lunit's AI biomarker—in predicting clinical outcomes of immunotherapy across more than 16 different cancer types....In addition, Lunit will also present clinical findings that demonstrate the accuracy of its AI imaging solution in detecting high-risk breast cancer patients."
Clinical data
|
Lunit SCOPE IO • Lunit SCOPE PD-L1
over2years
Observer performance study to examine the feasibility of the AI-powered PD-L1 analyzer to assist pathologists’ assessment of PD-L1 expression using tumor proportion score in non–small cell lung cancer. (ASCO 2022)
This study demonstrates that an AI-powered PD-L1 TPS analyzer can assist board-certified pathologists in evaluating TPS of NSCLC by improving the accuracy of TPS group evaluation and reducing the time to read slides.
PD(L)-1 Biomarker • IO biomarker • Tumor proportion score
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
PD-L1 IHC 22C3 pharmDx • Lunit SCOPE PD-L1