Seegene Launches Global Study on Comprehensive PCR Respiratory Testing

Molecular diagnostics company Seegene Inc. has launched the Global Million Clinical Study (GMCS), a large-scale initiative aimed at collecting clinical evidence for a shift from conventional virus-only testing to comprehensive syndromic PCR testing. This approach would allow for the simultaneous detection of both viral and pneumonia-associated bacterial pathogens.

An analysis of approximately 260,000 pediatric respiratory PCR test results, conducted using Seegene's STAgora™ platform, revealed that 78% of cases testing positive for respiratory viruses also carried pneumonia-causing bacterial pathogens. Conversely, 88% of cases positive for bacteria also showed co-detection of viral pathogens. This suggests that testing focused solely on viruses may miss a significant portion of concurrent bacterial infections.

The findings highlight the complex nature of respiratory infections, particularly in children, where viruses and bacteria frequently coexist. This prevalence of co-infections makes it challenging to identify the causative pathogen based on symptoms alone. Comprehensive PCR testing that detects multiple pathogens achieved a 96% positivity rate, with 82% of those results indicating the detection of at least two different pathogens.

Through GMCS, Seegene aims to demonstrate how comprehensive testing can improve diagnostics and treatment decisions in clinical settings worldwide. The study will evaluate how this testing methodology supports care pathways and patient management, with the goal of establishing a new global testing standard.