[Edaily Reporter SONG YOUNG-DOO ] Seegene Inc.(096530)Seegene is set to launch a global clinical study involving one million cases—a first in the diagnostic industry. The company’s vision goes beyond simply securing large-scale data; it aims to demonstrate the clinical value of disease-specific testing strategies and establish new global testing standards.

Seegene Inc., a global provider of total molecular diagnostic solutions, announced on the 8th that it will launch the “Global Million Clinical Study (GMCS)” project starting this August, targeting countries worldwide, including South Korea.

GMCS is a global clinical research project designed to verify the clinical utility and medical efficacy of disease-specific testing strategies based on one million cases of real-world data. Through this initiative, Seegene Inc. plans to establish a scientific basis for new testing standards, ensuring that patients receive the same level of diagnostic benefits regardless of their country or region.

The core of this project lies in validating the clinical value of the “syndromic PCR” testing strategy—which moves beyond existing single-pathogen-focused testing to simultaneously identify major causative pathogens with a single test. In actual clinical settings, this approach allows for additional analysis of hidden pathogens, co-infections, genotypes, and infection patterns by region and time—which were difficult to detect with conventional tests—using the same specimen while maintaining existing clinical and testing processes.

Seegene Inc. plans to conduct research targeting major infectious diseases such as respiratory infections, sexually transmitted infections, human papillomavirus (HPV) infections, and gastrointestinal infections. The goal is to obtain a broader range of clinical information from a single specimen collection and to evaluate how this information influences healthcare providers’ diagnostic and treatment decisions.

In particular, the real-world clinical data accumulated through GMCS will be integrated with Seegene Inc.’s real-time diagnostic data analysis platform, “STAgora™.” The company plans to use this to analyze the incidence patterns of infectious diseases by country and disease, as well as test results, and to utilize the data as a research foundation for establishing new testing criteria for each disease.

Seegene Inc. is focusing on this project due to differences in diagnostic environments across countries. While the latest molecular diagnostic technologies can provide the same level of diagnostic capability regardless of the country, in actual clinical settings, factors such as the pathogens tested for, recommended tests, and insurance coverage vary depending on each country’s systems and guidelines. This means that even for the same disease, the scope and level of diagnostics available to patients can differ.

Seegene Inc.’s strategy is to compare and analyze national testing systems and clinical guidelines to establish evidence for setting new global standards for each disease based on real-world clinical data. The company expects this project to contribute to the global expansion of molecular diagnostic technology and improved access to testing.

Seegene Inc. Chairman Cheon Jong-yoon stated, “GMCS is more than just a project to accumulate one million clinical data points; it is the diagnostic industry’s first global clinical research project on a scale of one million cases, designed to establish disease-specific testing strategies based on clinical evidence gathered in actual medical settings.” He added, “Seegene Inc. will not stop at developing excellent technology but will continue to accumulate objective clinical evidence to ensure that this technology can be adopted as new testing strategies in global healthcare settings.”

In particular, he emphasized, “Everyone around the world, regardless of country or region, has the right to receive the best possible testing currently available,” adding, “More comprehensive and accurate diagnostics are the starting point for improving patient treatment outcomes and detecting infectious diseases early to reduce their spread.”

Seegene Inc. was also recently included in the “World’s Most Impactful Companies 2026” list published by the U.S. newsweekly TIME. Through GMCS CORPORATION, the company plans to expand the molecular diagnostic technology and clinical expertise it has accumulated over the years into the global diagnostic ecosystem and present a new paradigm in the field of diagnostics.