Seegene has launched a global clinical study involving one million test cases to evaluate the clinical value of syndromic PCR testing for infectious diseases and generate real-world evidence that could inform future diagnostic approaches.

The Global Million Clinical Study (GMCS) will begin in South Korea before expanding to healthcare institutions worldwide. The project will collect large-scale clinical testing data to assess disease-specific testing strategies across major infectious diseases, including respiratory, gastrointestinal and reproductive tract infections.

Rather than relying on targeted testing for individual pathogens, the study will evaluate comprehensive syndromic PCR testing, which allows multiple pathogens to be detected from a single test. Seegene said the approach could provide additional clinical information, including co-infections, pathogen genotypes and regional or seasonal infection patterns that may not be captured through conventional testing.

The company plans to use the real-world data generated through the study to better understand how comprehensive molecular testing may support clinical decision-making across different healthcare settings.

As part of the project, Seegene will provide its STAgora data analytics platform to support analysis of pathogen prevalence and infection trends by disease type and geographical region.

Testing practices for infectious diseases vary considerably between countries because of differences in clinical guidelines, reimbursement policies and healthcare systems. Seegene said the study is intended to generate scientific evidence that could help inform future testing strategies based on data collected across multiple regions.

Dr Jong-Yoon Chun, chief executive officer 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.”

He added that the company’s aim is to build scientific evidence that supports improvements in diagnostic testing worldwide through the collection of real-world clinical data.

The study will initially focus on three major categories of infectious disease before expanding as additional data become available. Researchers will assess how comprehensive PCR testing performs in routine clinical practice and whether the information generated can support more informed diagnostic decisions.

Real-world evidence has become increasingly important in healthcare as researchers seek to understand how diagnostic technologies perform outside controlled clinical studies. Large datasets can also help identify epidemiological trends, including the emergence of co-infections and differences in pathogen prevalence between regions and seasons.

Seegene said the findings from GMCS are intended to contribute to the scientific evidence surrounding comprehensive syndromic PCR testing and support future discussions on disease-specific diagnostic strategies.