Joint development agreement for multi-cancer and disease prediction platform with 20/20 BioLabs, founded by Johns Hopkins alumni
Sweeping expansion of business scope to 30+ diseases, moving beyond the previous collaboration limited to kidney disease prediction
Joint initiation of an AI platform to preemptively enter the US healthcare market via the CLIA LDT system and pursue Medicare coverage
Complete establishment of core technologies across AI Prediction, Prevention, and Regeneration
Leaping forward as a cutting-edge AI healthcare regeneration platform company

AI hyper-personalized organ regeneration platform company ROKIT Healthcare (KOSDAQ: 376900, CEO You Seok-hwan) has signed a strategic Memorandum of Understanding (MOU) with 20/20 BioLabs, a US CLIA-certified specialized institution, for the "joint development of AI-based disease prediction and CLIA LDT (Laboratory Developed Test)."

The partner company, 20/20 BioLabs, is a specialized diagnostics firm established by experts from Johns Hopkins, one of the world's top medical schools, and possesses unparalleled clinical testing infrastructure and expertise.

This agreement significantly expands the scope of their existing partnership. While the MOU signed early this year and the definitive agreement concluded in March were limited to collaboration and a license-out royalty contract for Chronic Kidney Disease (CKD) prediction, this new MOU vastly broadens the collaboration to include the joint development of AI algorithms for over 30 multiple diseases and Multi-Cancer Early Detection (MCED).

The two companies will jointly verify and develop a next-generation MCED testing platform in the US and South Korea, collaborating on all fronts to advance ROKIT Healthcare's AI platform as a US CLIA LDT.

The core of this collaboration, which is drawing market anticipation, is the LDT business model utilizing the US CLIA (Clinical Laboratory Improvement Amendments) system. LDT is a regulatory pathway that allows certified laboratories to offer in-house developed testing services, enabling rapid clinical application once requirements are met.

Leveraging this, the two companies plan to officially launch the multi-cancer early detection and chronic disease risk prediction services for US medical institutions this November, aiming to generate immediate revenue and secure commercialization track records. Furthermore, after prioritizing the LDT process, they will jointly initiate an AI platform to secure Medicare coverage.

The platform being co-developed is a next-generation diagnostic solution that predicts the likelihood of over 30 major cancers and chronic diseases at an early stage. Going beyond simple single-disease testing, it seamlessly integrates MCED and chronic disease risk assessment within a single platform. To maximize accuracy, it employs an advanced AI algorithm that comprehensively analyzes vast amounts of multi-modal clinical data, including blood test results, genomic data, inflammatory markers, lifestyle information, and biomarker changes.

The global Multi-Cancer Early Detection (MCED) market is experiencing rapid growth at a CAGR of over 17%, projected to reach approximately $4.6 billion by the 2030s. Notably, similar companies in the US stock market that have successfully commercialized early diagnostics using the CLIA LDT track are recognized with high corporate valuations ranging from billions to tens of billions of dollars.

As of July 2026, blood-based cancer diagnostics company Guardant Health boasts a market capitalization of approximately $19.8 billion, while GRAIL, which commercialized the MCED test Galleri, is valued at around $2.9 billion.

Like these leading companies, ROKIT Healthcare's preemptive entry into the US market via the CLIA LDT model and the subsequent accumulation of real-world data are expected to serve as key drivers in the mid-to-long-term revaluation of the company's enterprise value.

Through this partnership, ROKIT Healthcare will further expand its diagnostic and predictive capabilities, maximizing synergy with its existing strengths in organ and tissue regeneration. As a result, ROKIT Healthcare is poised for robust growth as a cutting-edge AI healthcare regeneration platform company, fully equipped with core advanced technologies across AI prediction, prevention, and regeneration.

Beginning with a successful launch in the US market, the company plans to seamlessly execute comprehensive joint business initiatives, including establishing regulatory strategies, clinically validating AI models, securing a global distribution network, and accumulating real-world data for future application in the US insurance market.

An official from ROKIT Healthcare stated, "The collaboration with 20/20 BioLabs, comprised of experts from Johns Hopkins, presents the optimal opportunity to commercialize our AI disease prediction technology in the US market with maximum speed and profitability." They added, "As a next-generation healthcare platform encompassing the entire spectrum of AI prediction, prevention, and regeneration, we will achieve a successful US launch this November and establish ourselves as a game changer in the global precision medicine market."