The FDA-authorized assay simultaneously detects HSV-1, HSV-2, varicella-zoster virus, and monkeypox virus from a single sample to support faster differential diagnosis of viral skin lesions.
Seegene USA has received Emergency Use Authorization from the Food and Drug Administration for its Allplex HSV-1&2/VZV/MPXV assay. The multiplex real-time polymerase chain reaction (PCR) assay is designed to simultaneously detect and differentiate herpes simplex virus types 1 and 2, varicella-zoster virus, and monkeypox virus.
According to Seegene, the assay is the first multiplex PCR test in the US market designed to support the differential diagnosis of viral causes for ulcerative skin lesions. These pathogens frequently present with similar clinical symptoms, such as vesicular, pustular, and ulcerative lesions, which can be difficult to distinguish by appearance alone.
According to the company, testing for only one pathogen at a time can lead to missed diagnoses because cases caused by untested viruses may be overlooked. A study presented at the 2024 Clinical Virology Symposium evaluated 966 samples that had previously tested negative using single-pathogen methods. Researchers found that a multiplex PCR assay identified herpes simplex virus (HSV), varicella-zoster virus, or monkeypox virus in 54 of those samples, suggesting that single-target testing can leave a portion of cases undiagnosed.
The assay was developed at Seegene USA using the company’s proprietary PCR technologies, including Dual Priming Oligonucleotide, Tagging Oligonucleotide Cleavage and Extension, and Multiple Detection Temperatures. The company states these technologies allow for broad target coverage in a single reaction while maintaining the sensitivity and specificity required for multiplex testing.
“Seegene’s high-multiplex PCR technologies have been widely utilized across global markets,” says Jun Kim, CEO of Seegene USA, in a release. “This authorization marks an important step in bringing those capabilities more fully into the US market through Seegene USA, enabling the development of locally relevant multiplex diagnostic products that support US clinical laboratories and public-health needs.”
The authorization allows Seegene USA to expand its portfolio of multiplex PCR assays developed for the US market. The company also intends for this achievement to serve as a model for its broader initiative to support regional partners in developing and manufacturing molecular tests tailored to local needs. Through this global initiative, the company aims to strengthen local development capabilities and improve preparedness for future outbreaks.
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