Seegene will work with medical institutions worldwide to collect 1 million real patient test records to establish new disease-specific testing standards.
Seegene said on the 8th it will launch the Global Million Clinical Study (GMCS) project starting in Aug., targeting medical institutions in Korea and other countries.
GMCS is a study that verifies the clinical usefulness and medical impact of disease-specific testing strategies based on 1 million real patient test records. The goal is to establish scientific evidence for new testing strategies and present global testing standards.
The research will focus on major infectious diseases, including respiratory infections, sexually transmitted infections (STIs), human papillomavirus (HPV), and gastrointestinal infections. It will compare and analyze conventional tests and new testing strategies to verify diagnostic accuracy and clinical value.
The company aims to validate a "syndromic PCR" testing strategy. While conventional methods test each suspected pathogen individually, syndromic PCR is a molecular diagnostic technology that checks multiple viruses and bacteria at the same time with a single test. Seegene plans to assess whether this approach identifies pathogens and coinfections that conventional testing might miss and helps with patient care and treatment.
Data secured through the study will be linked to Seegene's real-time diagnostic data analysis platform STAgora to analyze patterns of infectious disease occurrence by country and by disease.
The company said testing targets, clinical guidelines, and insurance coverage criteria differ by country, creating gaps in testing scope and diagnostic standards even for the same disease. It plans to compare and analyze this with actual clinical data to establish scientific grounds for new global testing standards.
Cheon Jong-yoon, Seegene chairman, said, "GMCS is not simply a project to amass 1 million clinical data points, but research to build disease-specific testing strategies based on clinical evidence accumulated in real-world medical settings," adding, "We will continue to secure objective clinical evidence to establish the scientific foundation for new testing strategies."