Seoul, South Korea, August 10, 2026
Seegene Inc. has announced a comprehensive approach to syndromic PCR screening for reproductive tract infections, combining simultaneous detection of sexually transmitted infections (STIs) and human papillomavirus (HPV). The initiative builds on the company’s Global Million Clinical Study (GMCS), which aims to generate real-world clinical evidence to support a potential new global standard for PCR testing. Seegene’s approach is supported by an internal analysis of approximately 60,000 combined HPV and STI screening results collected over 42 months, providing evidence for further evaluation of comprehensive reproductive health screening.
STAgora Data Reveals High HPV and STI Co-Detection
Using its STAgora™ real-time testing data and statistical analytics platform, Seegene analyzed approximately 60,000 combined HPV and STI screening results. The analysis found that STI-causing pathogens were detected in 82% of HPV-positive cases, while HPV was detected in 46% of STI-positive cases. The company also reported that 71% of positive cases identified through comprehensive HPV and STI screening showed co-detection of HPV and STI-causing pathogens.
These findings support Seegene’s continued investigation into whether combining HPV and STI testing could provide additional clinical information compared with evaluating either group of pathogens separately. Potential applications identified by the company include screening for asymptomatic STIs, evaluating co-infections in HPV-positive individuals, and supporting reproductive health assessments associated with pregnancy preparation or infertility evaluation. The findings come from the company’s STAgora platform, which is designed to analyze real-time diagnostic data and support statistical evaluation of screening results. Seegene plans to continue collecting clinical data through the GMCS and use STAgora to evaluate the clinical utility and broader applicability of comprehensive HPV and STI screening.
Comprehensive Screening Addresses Reproductive Health Needs
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HPV is widely recognized as a major cause of cervical cancer, with certain high-risk genotypes, including HPV-16 and HPV-18, strongly associated with disease progression. Identifying the HPV genotype can provide important information for clinical management because screening and follow-up approaches may vary according to the specific genotype detected.
At the same time, STIs can be caused by multiple pathogens, including Chlamydia trachomatis and Neisseria gonorrhoeae, and can produce similar symptoms despite having different underlying causes. Symptoms may include abnormal discharge, painful urination, genital discomfort, lower abdominal pain, genital lesions, and infertility. Seegene also notes that asymptomatic infections are common, creating challenges for identifying infections based solely on symptoms. The company’s comprehensive approach is intended to provide broader molecular information by evaluating HPV and multiple STI pathogens simultaneously. Seegene states that emerging research connecting STIs, vaginal dysbiosis, and changes in the local cervical inflammatory and microbial environment provides a scientific rationale for further investigation of combined screening strategies.
Global Million Clinical Study to Validate Clinical Utility
The comprehensive screening initiative forms part of Seegene’s Global Million Clinical Study (GMCS), launched in July 2026. The global initiative is designed to collect real-world clinical data from healthcare facilities and evaluate disease-specific screening strategies using molecular diagnostic technologies.Through the GMCS, Seegene plans to gather additional evidence on the clinical utility of comprehensive HPV and STI screening and assess its applicability across different healthcare settings.
The company aims to use the resulting clinical evidence to contribute to the development of a potential new standard for PCR-based screening. Seegene’s syndromic real-time PCR technology is designed to detect multiple pathogens associated with similar symptoms within a single assay. The company is expanding this molecular diagnostics approach through technologies such as STAgora™, which supports diagnostic data analysis, and CURECA™, an automated PCR system designed to streamline molecular testing workflows. The latest findings represent an important step in Seegene’s efforts to investigate comprehensive molecular screening for reproductive tract infections. Further clinical validation through the GMCS will determine the broader clinical value and applicability of simultaneously assessing HPV and STI pathogens.
Source: Seegene press release
