• Virus-only testing may miss pneumonia-associated bacterial co-detections in 78% of virus-positive cases, while bacteria-only testing may miss viral co-detections in 88% of cases positive for pneumonia-associated bacterial pathogens
• Global Million Clinical Study (GMCS) to build clinical evidence supporting comprehensive syndromic PCR testing as a new global testing standard

SEOUL, South Korea, July 15, 2026 /PRNewswire/ -- Seegene Inc., a global molecular diagnostics company, announced the launch of the Global Million Clinical Study (GMCS), a large-scale initiative aimed at establishing clinical evidence for a transition from conventional virus-centered testing toward comprehensive syndromic PCR testing that simultaneously detects both viral and pneumonia-associated bacterial pathogens.

Using Seegene's statistical analytical platform, STAgora™, the company analyzed approximately 260,000 pediatric respiratory PCR test results collected over a 42-month period from children aged 0-5 years. The analysis found frequent co-detection of viral and pneumonia-associated bacterial respiratory pathogens, highlighting the complexity of pathogen detection patterns in pediatric respiratory infections.

The analysis revealed that respiratory viral panel testing yielded a positivity rate of 87%, and among these positive cases, 78% were also found to carry pneumonia-causing bacterial pathogens. Similarly, pneumonia-causing bacterial panel testing showed a positivity rate of 76%, with 88% of positive cases also testing positive for viral pathogens.

These findings highlight the complex nature of respiratory infections in young children, where viral and bacterial pathogens frequently coexist rather than occurring independently. These findings suggest that respiratory infections frequently involve multiple pathogen types and testing focused on a single pathogen category may not provide a complete picture of infection patterns.

The findings are particularly meaningful because pediatric respiratory infections can, in some cases, progress to serious conditions such as pneumonia or sepsis. They underscore the importance of obtaining comprehensive pathogen information, including both viruses and pneumonia-associated bacteria, early in the clinical evaluation process to support appropriate diagnostic and treatment decisions.

Additionally, the findings indicate that pathogen-specific testing alone may not adequately capture co-detection patterns that are frequently observed in real-world clinical settings. Comprehensive respiratory PCR testing showed a 96% positivity rate. Among those positive results, 82% involved the detection of at least two pathogens, further supporting the value of evaluating multiple potential respiratory infections at the same time.

Despite the complex nature of respiratory infections, testing in many healthcare settings remains largely focused on identifying viral infections, such as influenza virus, SARS-CoV-2, and respiratory syncytial virus (RSV). This trend was also reflected in an analysis of demand for approximately 19.5 million respiratory PCR tests supplied by Seegene across 62 countries over the past three years. The analysis showed that viral testing products accounted for approximately 80% of total demand, while products targeting pneumonia-causing bacteria accounted for about 20%.

However, respiratory symptoms such as rhinorrhea, cough, and fever are often similar regardless of whether the infection is caused by a virus or pneumonia-associated bacteria, making it difficult to identify the causative pathogen based on symptoms alone. This further underscores the importance of obtaining broad pathogen information early in the clinical evaluation process.

While pathogen-specific tests remain valuable for identifying individual targets, they may not provide a complete picture when multiple pathogens are involved simultaneously. Comprehensive syndromic PCR testing may help healthcare professionals better understand infection patterns and support more informed diagnostic and treatment decisions.

Seegene's comprehensive PCR-based testing approach is designed to detect respiratory viruses and major pneumonia-associated bacterial pathogens from a single specimen in a single test. The STAgora report provides intuitive visualization of co-detection patterns, pathogen combinations, distributions, and pathogen-specific Ct (cycle threshold) values. Going beyond simple positive-or-negative results, it enables assessment of the relative detection levels of individual pathogens in co-detection cases, supporting appropriate diagnostic and treatment decisions based on the characteristics of each infection.

Seegene suggests that comprehensive PCR testing represents an innovation in respiratory diagnostics by supporting a broader evaluation of infection causes and helping clinicians make more informed decisions regarding diagnosis and patient management.

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.

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.

About Seegene

Seegene is a global molecular diagnostics company with more than 25 years of expertise in research, development and manufacturing of syndromic real-time PCR technologies. The company is widely recognized for its proprietary multiplex PCR technology, which enables the simultaneous detection of multiple pathogens in a single test.

A core feature of Seegene's syndromic real-time PCR technology is its ability to detect up to 14 pathogens that cause similar signs and symptoms in a single tube while providing quantitative information to support more efficient clinical decision-making.

Seegene's technological capabilities were demonstrated during the COVID-19 pandemic, when the company supplied more than 340 million COVID-19 tests to over 100 countries worldwide.

Building on its molecular diagnostics expertise, Seegene is expanding beyond assay-based diagnostics to develop an integrated diagnostic ecosystem. The company is advancing new technologies including STAgora™, a real-time diagnostic data analytics platform, and CURECA™, a fully automated PCR system designed to streamline the entire molecular testing workflow.

Through its Technology Sharing Initiative and global partnerships, Seegene aims to broaden access to molecular diagnostics technologies and strengthen global preparedness for infectious diseases. 

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