Recent analysis indicates that diagnosing only viral infections in respiratory illnesses may lead to missed pneumonia pathogens.
On July 15, Seegene announced the need to shift the diagnostic paradigm for respiratory infections from a "virus-centric" approach to a comprehensive syndromic molecular diagnostic (PCR) test that simultaneously detects both viruses and pneumonia pathogens.
Using its statistical analysis platform, STAgora, Seegene analyzed approximately 260,000 respiratory PCR tests conducted on infants aged 0 to 5 over the past three and a half years (42 months). The analysis revealed a significant number of patients exhibited a pattern of "co-infection," where both viruses and pneumonia pathogens were detected simultaneously.
The analysis showed that among the cases confirmed positive by the virus panel test, 78% also detected pneumonia pathogens. Conversely, 88% of the positive pneumonia pathogen cases also showed the presence of viruses. The company stated, "Respiratory infections in infants can progress to severe conditions such as pneumonia or sepsis, making it crucial to identify various pathogens simultaneously at the initial treatment stage."
Furthermore, the analysis highlighted that single tests identifying only either viruses or pneumonia pathogens are insufficient to capture the common co-infection patterns seen in clinical practice. In fact, 82% of the cases that tested positive in the comprehensive PCR test for both viruses and pneumonia pathogens showed the presence of two or more pathogens.
Seegene's proposed syndromic PCR-based comprehensive test is designed to analyze major respiratory viruses and pneumonia pathogens from a single specimen. The STAgora report visually presents not only the co-infection status but also the combinations and distribution of pathogens, along with the Ct (Cycle threshold) values indicating infection intensity.
This approach allows for tailored treatment decisions based on the relative detection levels of each pathogen, moving beyond simple positive or negative results.
Seegene stated, "The syndromic PCR comprehensive test aims to support accurate diagnosis and treatment decisions through more comprehensive cause analysis," adding that it plans to secure large-scale clinical evidence through the Global Million Clinical Study (GMCS) starting next month.
Additionally, Seegene will launch the Global Million Clinical Study (GMCS) project in August, targeting medical institutions worldwide, including South Korea.
The GMCS aims to validate the clinical utility and medical effectiveness of testing strategies based on real patient data from 1 million tests. The goal is to establish scientific evidence for new testing strategies and propose global testing standards.
The study will focus on major infectious diseases, including respiratory infections, sexually transmitted infections (STIs), human papillomavirus (HPV), and gastrointestinal infections.
* This article has been translated by AI.
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