Seegene received Emergency Use Authorization from the FDA for its Allplex HSV-1&2/VZV/MPXV multiplex real-time PCR assay, designed to detect and differentiate viruses associated with ulcerative skin lesions. The test runs concurrently for herpes simplex virus 1/2, varicella-zoster virus, and mpox. Seegene said the assay helps reduce missed diagnoses when clinicians test one pathogen at a time, where cases caused by untested viruses can be overlooked. The company highlighted its proprietary multiplex PCR technologies and digitalized development system supporting assay performance. With the EUA, Seegene USA aims to expand locally relevant multiplex diagnostic products for U.S. laboratories, aligning with clinical and public-health needs for rapid differentiation in similar-looking lesion presentations.
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