Seegene has launched the Global Million Clinical Study (GMCS), aiming to evaluate the clinical utility and potential impact of comprehensive syndromic PCR testing approaches using real-world data
The project will begin in South Korea and at healthcare institutions worldwide to accumulate large-scale global testing data and assess the clinical value of disease-specific testing approaches for major infectious diseases. The project aims to develop the scientific basis for new global testing standards and support a more comprehensive and accurate diagnostic environment, in which everyone can access the best testing currently available, regardless of their country or region.
For this project, Seegene provides STAgora, a real-time testing data analytics platform intended to support statistical analysis of pathogen prevalence and infection trends across disease types and geographic regions.
GMCS aims to move past conventional targeted testing and assess the clinical value of comprehensive PCR testing, enabling the simultaneous detection of major causative pathogens in a single test.
The study will examine real-world testing data that has been difficult to capture through conventional testing alone, including previously undetected pathogens, co-infections, genotypes, and regional and seasonal epidemiological patterns.
The study will first focus on major infectious disease types, including reproductive tract, respiratory tract, and gastrointestinal tract infections. By doing so, the study aims to provide additional testing insights beyond those offered by existing methods and to assess how this information may support clinical decision-making.
Advanced PCR diagnostic technologies can provide a consistent level of diagnostic capability. However, actual testing practices may depend on each country’s healthcare environment. Even for the same disease, target pathogens, recommended testing protocols, and reimbursement policies can differ across national clinical guidelines and healthcare systems. This results in patients with the same disease having access to different levels and scopes of diagnostic testing, shaped by the testing strategies and healthcare systems of their respective countries.
Accordingly, Seegene is setting out to develop an important scientific evidence basis to accelerate new global testing standards aligned with real-world clinical needs.
Dr Jong-Yoon Chun, CEO and founder of Seegene, said, “GMCS goes beyond simply accumulating real-world testing data. It is the industry’s first global clinical study of this scale, designed to compile scientific evidence to help open a new paradigm in diagnostics.
“Innovation at Seegene does not end with developing advanced technologies. Our goal is to translate advanced technology into new testing strategies in the global healthcare environment. By continuously accumulating scientific evidence, we hope to bring better diagnostic options for patients.
“Everyone deserves access to high-quality diagnostic testing, regardless of where they live. More comprehensive and accurate diagnostics can support earlier and more informed clinical decision-making and help reduce the spread of infectious diseases. Through real-world clinical evidence generated by GMCS, we aim to support diagnostic strategies that allow patients worldwide to benefit from a high level of diagnostic excellence.”
