SEOUL, South Korea & IRVINE, Calif., July 21, 2026
Seegene USA has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Allplex™ HSV-1&2/VZV/MPXV Assay, marking an important advancement in molecular diagnostics for infectious diseases associated with ulcerative skin lesions. The newly authorized multiplex real-time PCR assay is the first test in the United States specifically designed to simultaneously detect and differentiate herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), varicella-zoster virus (VZV), and monkeypox virus (MPXV clades I/II and clade II) from a single patient sample. The authorization addresses a significant diagnostic challenge where multiple viral infections present with nearly identical clinical symptoms, allowing clinicians to identify the correct pathogen more rapidly while reducing the risk of missed diagnoses caused by single-target testing.
FDA Emergency Authorization Expands Multiplex Molecular Diagnostics
The Allplex™ HSV-1&2/VZV/MPXV Assay has been developed to provide simultaneous detection and differential diagnosis of four clinically important viral pathogens commonly associated with vesicular, pustular, and ulcerative skin lesions. Traditionally, healthcare providers often rely on separate molecular tests targeting individual pathogens, increasing diagnostic complexity and potentially delaying appropriate treatment decisions. By combining multiple viral targets into a single multiplex PCR assay, Seegene USA enables clinical laboratories to deliver faster and more comprehensive diagnostic information. The company noted that this represents the first multiplex PCR assay in the U.S. market specifically designed for the differential diagnosis of viral causes of ulcerative skin lesions, supporting more efficient patient management while improving laboratory workflow during routine testing and potential infectious disease outbreaks.
Advanced PCR Technology Improves Detection Accuracy
The newly authorized assay incorporates Seegene’s proprietary high-multiplex PCR technologies, including Dual Priming Oligonucleotide (DPO™), Tagging Oligonucleotide Cleavage and Extension (TOCE™), and Multiple Detection Temperatures (MuDT™), together with the company’s Digitalized Development System. These technologies enable simultaneous amplification and detection of multiple viral genetic targets within a single reaction while maintaining high analytical sensitivity and specificity. Supporting evidence presented during the 2024 Clinical Virology Symposium demonstrated the potential clinical value of multiplex testing. Researchers found that among 966 clinical samples previously reported as negative using single-pathogen assays, the multiplex PCR test subsequently identified HSV, VZV, or MPXV in 54 cases, highlighting that traditional single-target testing strategies may leave a meaningful number of infections undiagnosed. These findings reinforce the growing importance of multiplex molecular diagnostics in infectious disease detection.
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Strengthening U.S. Public Health Preparedness
According to Seegene USA, the FDA Emergency Use Authorization represents an important milestone in expanding its portfolio of locally developed multiplex molecular diagnostic assays tailored to the needs of U.S. clinical laboratories and public health programs. The authorization also supports Seegene’s broader Technology-Sharing Initiative, which aims to strengthen regional diagnostic manufacturing capabilities while enabling partners worldwide to develop advanced molecular tests addressing local infectious disease challenges. As emerging infectious diseases continue to pose global public health threats, the availability of highly sensitive multiplex PCR diagnostics capable of identifying multiple pathogens from a single specimen is expected to play an increasingly important role in improving outbreak preparedness, accelerating clinical decision-making, and supporting effective infection control strategies. The Allplex™ HSV-1&2/VZV/MPXV Assay further reinforces Seegene’s commitment to advancing next-generation molecular diagnostics for modern healthcare systems.
Source: Seegene Press release
