Seegene USA Inc. has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Allplex HSV1-1&2/VZV2/MPXV3 Assay, a multiplex real-time PCR test designed to simultaneously detect multiple viral pathogens associated with clinically overlapping lesion presentations.

Unlike current molecular tests that target only a single pathogen or a limited pathogen group, Seegene’s new assay can concurrently detect herpes simplex virus type 1 and type 2 (HSV-1, HSV-2), varicella-zoster virus (VZV), and monkeypox virus (MPXV clades I/II and MPXV clade II) in a single test. The Allplex HSV-1&2/VZV/MPXV Assay is the first U.S. Multiplex PCR4 test designed to simultaneously and differentially detect viral pathogens of ulcerative skin lesions.

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. This product addresses the unmet market need 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 at Seegene USA using its 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, according to the company.

“Seegene’s high-multiplex PCR technologies have been widely utilized across global markets,” Seegene USA CEO Jun Kim said. “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, executives claim. As the initiative expands globally, Seegene aims to strengthen local development and manufacturing capabilities and improve preparedness for future outbreaks.

Seegene is a global molecular diagnostics company with more than 25 years of expertise in research, development, and manufacturing of syndromic real-time PCR technologies. The company is recognized for its proprietary multiplex PCR technology, which enables the simultaneous detection of multiple pathogens in a single test. A core feature of Seegene’s syndromic real-time PCR technology is its ability to detect up to 14 pathogens that cause similar signs and symptoms in a single tube while providing quantitative information to support more efficient clinical decision-making.

Seegene’s technological capabilities were demonstrated during the COVID-19 pandemic, when the company supplied more than 340 million COVID-19 tests to over 100 countries worldwide.

Building on its molecular diagnostics expertise, Seegene is expanding beyond assay-based diagnostics to develop an integrated diagnostic ecosystem. The company is advancing new technologies, including STAgora, a real-time diagnostic data analytics platform, and CURECA, a fully automated PCR system designed to streamline the entire molecular testing workflow. Through its Technology Sharing Initiative and global partnerships, Seegene aims to broaden access to molecular diagnostics technologies and strengthen global preparedness for infectious diseases. 

References
1 Herpes simplex virus (HSV) is a common viral pathogen that causes oral and genital herpes infections. HSV-1 is primarily associated with oral herpes, while HSV-2 is more commonly linked to genital herpes. Molecular diagnostic testing can support accurate detection and differentiation of HSV infections.
2 Varicella-zoster virus (VZV) is a member of the herpesvirus family that causes chickenpox (varicella) during primary infection and shingles (herpes zoster) upon reactivation. Early and accurate detection of VZV can assist in the diagnosis and management of related infections.
3 Monkeypox virus (MPXV) is a zoonotic orthopoxvirus that causes mpox, a viral disease characterized by skin lesions, fever, and lymph node swelling. Laboratory testing, including molecular diagnostics, plays an important role in confirming infection and supporting public health surveillance.
4 Multiplex PCR is a molecular diagnostic technique that enables the simultaneous detection and analysis of multiple target genes or pathogens in a single reaction. By testing for several targets at once, multiplex PCR can improve diagnostic efficiency, reduce turnaround time, and support comprehensive identification of infectious diseases.