Seegene Launches Industry's First Global Million Clinical Study to Shape New Disease-Specific Testing Standards

This project is scheduled to begin in South Korea and at healthcare institutions across the world to accumulate large-scale global testing data and assess the clinical value of disease-specific testing approaches for major infectious diseases. The goal is to build the scientific basis for new global testing standards and support a more comprehensive and accurate diagnostic environment, in which everyone, regardless of country or region, can access the best testing currently available.

For this project, Seegene provides STAgora™, a real-time testing data analytics platform. The platform is intended to support statistical analysis of pathogen prevalence and infection trends across disease types and geographic regions.

• GMCS to Generate Real Testing Data While Maintaining Existing Clinical Practice

GMCS aims to go beyond conventional targeted testing and assess the clinical value of comprehensive PCR testing that enables the multiple detection of major causative pathogens in a single test. The study will analyze real-world testing data that has been difficult to fully capture through conventional testing alone, including previously undetected pathogens, co-infections, genotypes, and regional and seasonal epidemiological patterns.  

• Evaluating Disease-Specific Diagnostic Strategies

The study will initially focus on major infectious disease types, including reproductive tract infections, respiratory tract infections and gastrointestinal tract infections. By doing so, the study aims to bring additional testing insights beyond those provided by existing testing methods and assess how this information may support clinical decision-making.

• Creating Evidence-Based Insights for New Testing Standards

State-of-the-art 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 differ according to national clinical guidelines and healthcare systems. This means that patients with the same disease may have access to different levels and scopes of diagnostic testing, shaped by the testing strategies and healthcare systems of their respective countries.

Accordingly, Seegene aims to build an important scientific evidence basis to drive new global testing standards aligned with real-world clinical needs.

"GMCS goes beyond simply accumulating real-world testing data," said Dr. Jong-Yoon Chun, CEO & Founder of Seegene. "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," Dr. Chun added. "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."

Dr. Chun also emphasized the company's long-term vision of expanding access to high-quality diagnostics worldwide.

"Everyone deserves access to high-quality diagnostic testing, regardless of where they live," he said. "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."

Notice

GMCS is an evidence-generation initiative and does not constitute medical advice, diagnostic guidance or a product-specific performance claim.

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SOURCE Seegene