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Bio & Pharma

Lunit receives $1 mn in tech fees from Guardant Health of US

The AI-based pathology analysis solution Lunit Scope PD-L1 has received crucial verification from CLIA

By Mar 08, 2023 (Gmt+09:00)

1 Min read

Lunit Scope PD-L1
Lunit Scope PD-L1

The US operations of South Korea's artificial intelligence (AI) medical company Lunit have received a major boost after the company got the green light for use of its products at facilities requiring Clinical Laboratory Improvement Amendments (CLIA) certification, an American lab standard.  

Lunit on Tuesday said it will receive $1 million in technology fees from Guardant Health, a leading American company in liquid biopsy that tests cancer markers with blood that also supervises US distribution of Lunit Scope PD-L1, an AI-based pathology analysis solution. Guardant Health's products are used by 80% of US-based professors in hemato-oncology.

Guardant Health's verification procedures led to certification of Lunit Scope PD-L1 for use at CLIA-certified labs, with the product expected to see boosted sales on the American market thanks to the certification. The technology fee earned stemmed from successful verification of laboratory developed tests (LDTs) used at CLIA-certified facilities.

Lunit Scope PD-L1 is grafted on Guardant Health's tissue biopsy test Guardant360 TissueNext to accurately analyze the degree of expression of the cancer biomarker PD-L1. This certification will allow Lunit to expand this product's use to clinical tests such as those for non-small cell lung cancer, triple-negative breast cancer and bladder cancer.

In the first half of this year, the company will complete additional LDT verification for 10 cancer types.

Write to Ji-Hyun Lee at bluesky@hankyung.com
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