• First CE Mark for Lunit AI-powered pathology solution

• Lunit to focus on launching ‘Lunit SCOPE PD-L1’ in Europe within the second half of 2022

Lunit, a leading medical AI provider, today announced it has received the CE-IVDD Mark for ‘Lunit SCOPE PD-L1 TPS’, an AI-based PD-L1 tumor proportion score (TPS) analyzer. While Lunit’s INSIGHT product scored the CE Mark in 2019 and 2020, this is the first time for a Lunit SCOPE product to receive European approval.

Lunit SCOPE PD-L1 is an AI solution that performs PD-L1 TPS classification that enhances objective and accurate analysis compared to traditional method.

The product, trained with more than 1,000,000 cancer cell images, precisely analyzes PD-L1 biomarker expression and classifies PD-L1 TPS into three groups: 50% or more, 1-49%, and 0%. This digitized assistance substantially supports pathologists in diagnosing the status with high accuracy and consistency in analysis performance.

“This CE Mark certification is a meaningful milestone,” said Brandon Suh, CEO of Lunit. “It demonstrates the expansion of Lunit’s offerings to the cancer biopsy field beyond the scope of medical image analysis. As our AI technology gains reliability and recognition, we will do our utmost to pioneer the overseas market.”

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.