Lunit Receives $1 Million in KOLAS Certification Royalties from US Guardant Health

Medical AI company Lunit announced on the 6th that it has completed the validation of its AI pathology analysis solution 'Lunit Scope PD-L1' in the CLIA LAB laboratory-developed test (LDT) for entry into the US market.

AI-based pathology analysis solution 'Lunit Scope PD-L1'
[Photo by Lunit]

This LDT was conducted at Gardant Health's CLIA LAB, a US biohealthcare company. Under the joint research and development agreement between the two companies, Lunit will receive a technology fee of $1 million (approximately 1.3 billion KRW) from Gardant Health.

CLIA is a system in which the US Centers for Medicare & Medicaid Services evaluates the environmental standards necessary for diagnostics such as specimen testing. Obtaining this certification allows products and services to be sold in the US market. LDT refers to a system that permits certified CLIA laboratories to perform diagnostic and testing services developed in-house.

With the successful completion of this LDT validation to expand clinical testing to non-small cell lung cancer, triple-negative breast cancer, and bladder cancer, Lunit will receive the technology fee. Lunit plans to complete CLIA LAB LDT validations for about 10 cancer types by the first half of this year.

Lunit explained that this LDT validation is an extension of the additional development of 'Gardant360 TissueNext,' which was jointly released to the global market with Gardant Health based on Lunit Scope PD-L1. Gardant360 TissueNext is a product that analyzes the expression level of the biomarker 'PD-L1,' a protein on the surface of cancer cells that predicts the effectiveness of immuno-oncology treatments.

Seobum Seok, CEO of Lunit, said, "By successfully completing this CLIA LAB LDT validation, we have elevated our technological competitiveness to a new level," adding, "Since Gardant Health has secured large-scale distribution and sales channels in the US, we expect to continue meaningful growth in the future."

This content was produced with the assistance of AI translation services.