Seegene Launches Industry's First "Global Million Clinical Study"

Establishing New Global Diagnostic Standards for Each Disease

Global molecular diagnostics total solution provider Seegene announced on July 8 that it will be launching the industry's first "Global Million Clinical Study (GMCS)" project.

The GMCS project will begin in August this year and will be conducted in countries worldwide, including Korea. It is the first industry initiative to collect and analyze real-world clinical data from one million tests, aiming to validate the clinical utility and medical impact of new, disease-specific testing strategies through a global clinical research project.

The goal of this project is for medical institutions around the world to jointly accumulate real-world clinical data and, based on this, verify the clinical value of disease-specific testing strategies. The project aims to provide scientific evidence for the establishment of a Global New Standard for diagnostics. Its objective is to create a more comprehensive and accurate diagnostic environment so that anyone, regardless of country or region, can access the best available testing.

Seegene has positioned its real-time diagnostic data analysis platform, STAgora™, at the center of these data-driven studies and the accumulation of clinical evidence. Real-world clinical data gathered through the GMCS will be integrated with STAgora to analyze the occurrence patterns and test results of infectious diseases by country and disease, and will serve as a research foundation for establishing new disease-specific testing standards.

Existing Medical Practice Maintained... Clinical Evidence Secured Through Real-World Data

The GMCS was designed to move beyond traditional single-pathogen testing and validate the clinical value of syndromic PCR-based testing strategies that can simultaneously identify major causative pathogens with a single test.

The core of the project is to analyze, using real-world clinical data, previously undetected pathogens, co-infections, genotypes, and region- or time-specific epidemiological patterns that are difficult to detect with conventional testing. This approach will provide the necessary clinical evidence for more effective diagnosis and patient management. The accumulated real-world clinical data will serve as the research basis for validating the clinical value of disease-specific testing strategies and will become the foundation for developing new diagnostic approaches in the future.

To establish clinical evidence for new disease-specific testing strategies, Seegene aims to realize comprehensive testing through single-sample collection. The company plans to validate the clinical value of testing approaches that offer broader clinical information for major infectious diseases—such as respiratory infections (RP), sexually transmitted infections and human papillomavirus (HPV), and gastrointestinal infections (GI)—compared to existing tests, and to amass practical data needed to develop disease-specific testing approaches.

The GMCS will be conducted by comparing and analyzing conventional testing methods and new diagnostic strategies as they are actually used in healthcare settings. While entirely maintaining current medical and testing processes, the project will use the same samples to further analyze pathogens and co-infections, as well as infection patterns for each disease that are hard to detect with conventional testing. The key is to secure more clinical information than is currently possible, and to evaluate the value that this additional information provides for actual clinical decision-making.

Seegene was recently included in the 'World's Most Impactful Companies 2026' announced by the American weekly news magazine TIME. Seegene

Establishing a Scientific Basis for New Global Standards

Although the latest molecular diagnostic technologies can deliver equivalent diagnostic capabilities regardless of country, in practice, testing strategies and diagnostic scope still vary greatly depending on each country's medical environment. Even for the same disease, the target pathogens, recommended tests, and insurance coverage can differ depending on local medical systems and clinical guidelines.

As a result, even healthcare professionals treating the same disease may select different testing strategies based on their country's policies, leading to differences in the scope and level of diagnosis available to patients.

To achieve robust clinical design, Seegene's strategy is to objectively compare national testing systems and clinical guidelines and to secure scientific evidence for establishing new global standards for disease-specific testing, all based on real-world clinical data.

Chun Jong-yoon, CEO of Seegene, stated, "The GMCS is more than just a project to accumulate one million clinical datasets—it is the industry's first global clinical research project of this scale to build disease-specific testing strategies based on clinical evidence collected from real clinical settings, thereby opening a new paradigm in diagnostics. Seegene is committed not only to developing advanced technologies but also to continuously accumulating objective clinical evidence to establish a scientific foundation for new diagnostic strategies, so that these technologies can spread as new diagnostic strategies in the global healthcare field and benefit more patients with better diagnostics."

He added, "Everyone around the world, regardless of country or region, has the right to access the best possible testing available today. More comprehensive and accurate diagnostics are the starting point for improving patient outcomes and for early detection and containment of infectious diseases. Seegene will continue to build the scientific foundation of new global diagnostic standards based on real-world clinical data and evidence, so that everyone can benefit from the same level of diagnostics."

Seegene was recently included in the "World's Most Impactful Companies 2026" announced by the American news magazine TIME, and plans to lead a new paradigm in the global diagnostics field.

This content was produced with the assistance of AI translation services.