Seegene USA has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Allplex HSV-1&2/VZV/MPXV Assay, a multiplex real-time PCR assay designed to simultaneously detect multiple viral pathogens associated with clinically overlapping lesion presentations.

The assay is designed to enable the concurrent detection of herpes simplex virus type 1 and type 2 (HSV-1, HSV-2), varicella-zoster virus (VZV), and monkeypox virus (MPXV) in a single test. The Allplex HSV-1&2/VZV/MPXV Assay is the first multiplex PCR test designed to simultaneously and differentially detect viral pathogens of ulcerative skin lesions in the U.S. market.

In a poster presented at the 2024 Clinical Virology Symposium, scientists evaluated samples that had previously tested negative using single-pathogen methods and found that a multiplex PCR assay identified HSV, VZV, or MPXV clade I/II in 54 out of 966 of those samples, pointing to a meaningful population of cases that single-target testing can leave undiagnosed.

The Allplex HSV-1&2/VZV/MPXV Assay was developed end-to-end at Seegene USA using Seegene’s proprietary high-multiplex PCR technologies, including Dual Priming Oligonucleotide (DPO), Tagging Oligonucleotide Cleavage and Extension (TOCE), and Multiple Detection Temperatures (MuDT), and its automated product development platform (Seegene Digitalized Development System). These technologies enable comprehensive target coverage in a single reaction while maintaining the sensitivity and specificity required for reliable multiplex testing.

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