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www.fdanews.com/articles/207621-lunit-ai-analysis-software-for-cancer-protein-pd-l1-gets-ce-ivd-mark

Lunit AI Analysis Software for Cancer Protein PD-L1 Gets CE-IVD Mark

May 2, 2022

South Korea-based Lunit has received a CE-IVD mark for its artificial intelligence (AI) analysis software that focuses on the cancer-associated protein PD-L1.

The Scope PD-L1 TPS software, which delivers a tumor proportion score (TPS), was “trained” to identify the biomarker using more than 1 million cancer cell images. The software precisely analyzes PD-L1 biomarker expression and then classifies the PD-L1 TPS into three groups: 50 percent or more, 1-49 percent and 0 percent. The score helps pathologists in assessing the status of their cancer patients.

Lunit said it plans to launch the Lunit Scope PD-L1 software in Europe in the second half of this year.

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