Seegene has launched the Global Million Clinical Study (GMCS), an international research initiative designed to generate clinical evidence supporting broader use of syndromic PCR testing for respiratory infections.

The programme will investigate whether testing for both viral and pneumonia-associated bacterial pathogens at the same time could improve diagnosis and clinical decision-making compared with conventional pathogen-specific testing.

The announcement follows an analysis of approximately 260,000 paediatric respiratory PCR test results collected over 42 months from children aged between zero and five years using Seegene’s STAgora analytical platform.

According to the company, respiratory viral panel testing produced an 87% positivity rate, with 78% of virus-positive samples also containing pneumonia-associated bacterial pathogens. Likewise, bacterial panel testing identified bacterial pathogens in 76% of samples, while 88% of those positive cases also tested positive for respiratory viruses.

The findings suggest that viral and bacterial pathogens frequently coexist in young children with respiratory infections and that testing focused on a single pathogen group may not provide a complete picture of infection patterns.

Comprehensive respiratory PCR testing achieved an overall positivity rate of 96%, with 82% of positive samples containing at least two detectable pathogens, according to the analysis.

Seegene also reviewed demand for approximately 19.5 million respiratory PCR tests supplied across 62 countries over the past three years. The company found that virus-only testing accounted for around 80% of demand, compared with around 20% for tests targeting pneumonia-associated bacteria.

The company said respiratory symptoms such as cough, fever and rhinorrhoea are often similar regardless of whether an infection is caused by viral or bacterial pathogens, making laboratory testing important when determining the underlying cause.

Seegene said: “Beginning in August, the company will launch GMCS to generate large-scale real-world clinical evidence on the value of comprehensive PCR testing across diverse healthcare settings worldwide.”

The company added: “Through GMCS, Seegene plans to evaluate how comprehensive testing can support clinical decision-making across diagnosis and treatment pathways. The company intends to use the study findings to verify the clinical usefulness of comprehensive, symptom-based syndromic PCR testing and contribute to the establishment of global new standards for respiratory infection diagnostics.”

The Global Million Clinical Study will begin in August and is intended to generate real-world evidence from multiple healthcare settings worldwide to assess the clinical value of comprehensive syndromic PCR testing for respiratory infections.