Original from: PR Newswire
Seegene, Inc. ("Seegene"), a global leader in molecular diagnostics, announced today that its U.S. subsidiary, Seegene USA, Inc. ("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.
Unlike molecular tests currently available that target a single pathogen or a limited pathogen group, 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.
These pathogens frequently present with similar clinical symptoms, vesicular or pustular lesions, that are difficult to distinguish by appearance alone. When clinicians test for only one pathogen at a time, cases caused by the untested viruses can be missed entirely. This product addresses the unmet need in the market for simultaneous evaluation of multiple clinically overlapping pathogens in a single assay.
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.
"Seegene's high-multiplex PCR technologies have been widely utilized across global markets," said Jun Kim, CEO of Seegene USA. "This authorization marks an important step in bringing those capabilities more fully into the U.S. market through Seegene USA, enabling the development of locally relevant multiplex diagnostic products that support U.S. clinical laboratories and public-health needs."
With this authorization, Seegene USA is positioned to expand its portfolio of locally developed multiplex PCR assays for the U.S. market. The achievement also serves as a meaningful model for Seegene's broader Technology-Sharing Initiative, which supports regional partners in developing and manufacturing multiplex molecular tests tailored to local needs. As the initiative expands globally, Seegene aims to strengthen local development and manufacturing capabilities and improve preparedness for future outbreaks.
Source: Seegene USA Receives FDA Emergency Use Authorization for Multiplex PCR Assay, Advancing Differential Diagnosis of HSV-1&2, VZV, and Monkeypox Virus for Ulcerative Skin Lesions
