ROKIT Healthcare(376900) is joining hands with a U.S. clinical testing agency to commercialize in the United States an artificial intelligence (AI)-based early diagnosis service for cancer and chronic diseases. The goal is to launch by the end of this year a service at U.S. hospitals that predicts the risk of cancer and chronic diseases through blood tests.
ROKIT Healthcare said on the 24th it signed a memorandum of understanding (MOU) with 20/20 BioLabs for the joint development of AI-based disease prediction and testing services.
With this agreement, the two sides decided to expand their collaboration, previously limited to predicting chronic kidney disease (CKD), to multi-cancer early detection (MCED) and prediction of about 30 cancers and chronic diseases.
The two sides plan to jointly develop a platform that uses AI to analyze blood test results, genomic information, inflammation markers, and lifestyle data to predict the likelihood of disease onset. After validating performance in the United States and Korea, they intend to launch the service targeting U.S. medical institutions.
The company aims to introduce multi-cancer early screening and chronic disease risk prediction services at U.S. medical institutions in Nov.
The key to this collaboration is leveraging the U.S. CLIA (Clinical Laboratory Improvement Amendments) system. CLIA is a certification program run by the U.S. government to manage the accuracy and quality of clinical laboratories, and laboratories certified under CLIA can provide their own developed testing services in clinical settings.
Tests developed and provided by laboratories in this way are called laboratory developed tests (LDTs). Unlike in vitro diagnostic medical devices sold after obtaining separate product approval, they are provided as medical services by certified laboratories, which is a distinguishing feature. Because of this, new diagnostic technologies can be applied to clinical settings relatively quickly, and U.S. Digital Healthcare corporations are using this as an initial commercialization strategy.
ROKIT Healthcare plans to first enter the U.S. market with the LDT approach, accumulate real-world testing data, and later pursue insurance coverage and additional approvals.