Lunit AI-Powered Pathology Solution Aids Highly Accurate Cancer Diagnosis

Programmed death ligand 1 (PD-L1) expression is the standard biomarker in advanced non-small cell lung cancer (NSCLC). However, manual evaluation of PD-L1 tumor proportion score (TPS) by pathologists has practical limitations of interobserver bias, variation in subjectivity on the area of interest, and intensive labor. Now, a new artificial intelligence (AI)-powered TPS analyzer could reduce the human discrepancy.

Lunit’s (Seoul, Korea) Lunit SCOPE PD-L1 TPS, an AI-based PD-L1 TPS analyzer, performs PD-L1 TPS classification which enhances objective and accurate analysis as compared to the 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.

Lunit has received the CE-IVDD Mark for the Lunit SCOPE PD-L1 TPS. 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. The company 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.

"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."

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