The initiative will collect real-world clinical data to assess the value of multi-pathogen PCR testing and help inform future diagnostic standards.
Seegene has launched the Global Million Clinical Study to evaluate the clinical utility and potential impact of syndromic polymerase chain reaction (PCR) testing approaches using real-world data.
The study is scheduled to begin in South Korea and at healthcare institutions worldwide to accumulate global testing data and assess the clinical value of disease-specific testing for major infectious diseases. The goal is to build a scientific basis for global testing standards and support a diagnostic environment where patients have access to the best available testing regardless of region.
For the project, Seegene is providing STAgora, a real-time testing data analytics platform. The platform supports statistical analysis of pathogen prevalence and infection trends across disease types and geographic regions, according to the release.
Evaluating Diagnostic Strategies
The Global Million Clinical Study aims to assess the clinical value of PCR testing that enables the detection of multiple causative pathogens in a single test. The study will analyze real-world data that is often difficult to capture through conventional testing, including previously undetected pathogens, co-infections, genotypes, and seasonal epidemiological patterns.
The study will initially focus on major infectious disease types, including reproductive tract infections, respiratory tract infections, and gastrointestinal tract infections. Through these focus areas, the study aims to provide testing insights beyond existing methods and assess how this information supports clinical decision-making.
“[Global Million Clinical Study] goes beyond simply accumulating real-world testing data,” says Jong-Yoon Chun, CEO and founder of Seegene, in a release. “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.”
Establishing Global Standards
While PCR diagnostic technologies provide a consistent level of capability, actual testing practices often depend on a country’s healthcare environment. Target pathogens, recommended testing protocols, and reimbursement policies vary according to national clinical guidelines and healthcare systems.
Seegene aims to build a scientific evidence basis to drive new global testing standards aligned with real-world clinical needs.
“Innovation at Seegene does not end with developing advanced technologies,” says Chun in a release. “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.”
Chun also emphasized the vision of expanding access to diagnostics worldwide.
“Everyone deserves access to high-quality diagnostic testing, regardless of where they live,” says Chun in a release. “More ‘comprehensive’ and accurate diagnostics can support earlier and more informed clinical decision-making and help reduce the spread of infectious diseases.”
