Seegene Initiates Clinical Study to Shape New Disease-Specific Testing Standards

Seegene has launched the Global Million Clinical Study (GMCS), an initiative that aims to evaluate the clinical utility and potential impact of comprehensive syndromic PCR testing approaches using real-world data.

The project is beginning 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 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.

Seegene is providing STAgora, a real-time testing data analytics platform, for this project. 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 goes beyond traditional targeted testing and assesses the clinical value of comprehensive PCR testing that detects multiple major pathogens in a single test. The study will analyze real-world testing data that conventional testing alone has struggled to capture, including previously undetected pathogens, co-infections, genotypes, and regional and seasonal epidemiological patterns.  

“GMCS goes beyond simply accumulating real-world testing data,” Seegene Founder/CEO Dr. Jong-Yoon Chun said. “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.”

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 the way 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. Thus, 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.

Dr. Chun 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 stated. “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.”

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

Seegene is a global molecular diagnostics company with more than 25 years of expertise in research, development, and manufacturing of syndromic real-time PCR technologies. The company is recognized for its proprietary multiplex PCR technology, which enables the simultaneous detection of multiple pathogens in a single test. A core feature of Seegene’s syndromic real-time PCR technology is its ability to detect up to 14 pathogens that cause similar signs and symptoms in a single tube while providing quantitative information to support more efficient clinical decision-making.

Seegene’s technological capabilities were demonstrated during the COVID-19 pandemic, when the company supplied more than 340 million COVID-19 tests to over 100 countries worldwide.

Building on its molecular diagnostics expertise, Seegene is expanding beyond assay-based diagnostics to develop an integrated diagnostic ecosystem. The company is advancing new technologies, including STAgora, a real-time diagnostic data analytics platform, and CURECA, a fully automated PCR system designed to streamline the entire molecular testing workflow. Through its Technology Sharing Initiative and global partnerships, Seegene aims to broaden access to molecular diagnostics technologies and strengthen global preparedness for infectious diseases.