Lunit's AI Pathology Analysis Solution 'Lunit Scope PD-L1' Receives European CE Certification

Lunit's 'Lunit SCOPE PD-L1 TPS'

[Asia Economy Reporter Chunhee Lee] Lunit announced on the 27th that its artificial intelligence (AI) pathology analysis solution, 'Lunit SCOPE PD-L1 TPS,' has obtained the European medical device certification (CE-IVDD).

Lunit SCOPE PD-L1 is a product that analyzes the tumor proportion score (TPS) of the PD-L1 biomarker, used to predict the therapeutic response to immune checkpoint inhibitors, more objectively and accurately through AI trained on over one million cancer cell images. It quantifies the expression level of the PD-L1 biomarker more precisely as a tumor proportion score and subdivides it into three groups: 50% or more, 1?49%, and 0%, enabling objective and consistent analysis.

With this CE certification, Lunit plans to accelerate efforts to enable sales in the European market within the second half of the year by supplying Lunit SCOPE PD-L1 to Europe.

Seobeom Seok, CEO of Lunit, said, "Obtaining the European CE certification is significant as it expands Lunit's marketability from Lunit INSIGHT, which was approved in the US and Europe for medical imaging, into the pathology field. With this certification proving Lunit's AI technology and expertise, we will actively pursue overseas market development."

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