Seegene received Emergency Use Authorization from the FDA for a multiplex real-time PCR assay designed to detect and differentiate HSV-1, HSV-2, VZV, and mpox (MPXV) from ulcerative skin lesions. The Allplex HSV-1&2/VZV/MPXV Assay aims to reduce missed infections that can occur when clinicians test only one pathogen at a time. The assay leverages Seegene’s high-multiplex PCR technologies, including Dual Priming Oligonucleotide (DPO), Tagging Oligonucleotide Cleavage and Extension (TOCE), and Multiple Detection Temperatures (MuDT), alongside the Seegene Digitalized Development System. Seegene said the EUA is a step toward expanding local, US-relevant multiplex diagnostic offerings for clinical laboratories and supporting public health needs. It also highlighted that the underlying multiplex PCR technology has already been used across global markets. For diagnostic manufacturers and lab networks, the EUA highlights how rapidly US in-vitro diagnostics are being adapted to simultaneously cover overlapping clinical presentations and emerging public health concerns.