Seegene USA receives FDA Emergency Use Authorization for multiplex PCR assay

Seegene, Inc. has announced that its U.S. subsidiary, Seegene USA, Inc. (‘Seegene US’), 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.

This multiplex real-time PCR assay is designed to simultaneously detect and differentiate herpes simplex virus types 1 and 2 (HSV-1 and HSV-2), varicella-zoster virus (VZV), and monkeypox virus (MPXV clades I/II and clade II) from ulcerative skin lesions in a single test, supporting more accurate and efficient differential diagnosis in U.S. clinical laboratories.

The Allplex™ HSV-1&2/VZV/MPXV Assay is designed to support simultaneous and differential detection of viral pathogens associated with ulcerative skin lesions in the U.S. market. Unlike molecular tests that target a single pathogen or a limited pathogen group, this assay enables concurrent detection of herpes simplex virus type 1 (HSV-1¹), herpes simplex virus type 2 (HSV-2²), varicella-zoster virus (VZV³), and monkeypox virus (MPXV⁴) in a single test.

These pathogens are associated with clinically overlapping vesicular, pustular, and ulcerative lesions that are difficult to distinguish by appearance alone. By providing simultaneous detection and differentiation, the assay is designed to help clinicians and laboratories more efficiently identify the viral cause of ulcerative skin lesions and support appropriate patient management.

Addressing missed diagnoses with multiplex PCR testing

When clinicians test for only one pathogen at a time, cases caused by untested viruses can be missed entirely, leaving a proportion of patients without a confirmed diagnosis. The Allplex™ HSV-1&2/VZV/MPXV Assay addresses this unmet need by enabling simultaneous evaluation of multiple clinically overlapping pathogens in a single assay.

In a poster presented at the 2024 Clinical Virology Symposium⁵, scientists evaluated samples that had previously tested negative using single-pathogen methods. A multiplex PCR assay identified HSV, VZV, or MPXV clade I/II in 54 out of 966 of those samples, indicating a meaningful population of cases that single-target testing can leave undiagnosed. This finding underscores the potential clinical value of multiplex PCR testing for patients presenting with vesicular, pustular, or ulcerative lesions.

Developed using Seegene’s proprietary high-multiplex PCR technologies

The Allplex™ HSV-1&2/VZV/MPXV Assay was developed end-to-end at Seegene USA using Seegene’s proprietary high-multiplex PCR technologies. These include Dual Priming Oligonucleotide (DPO™), Tagging Oligonucleotide Cleavage and Extension (TOCE™), and Multiple Detection Temperatures (MuDT™), as well as Seegene’s automated product development platform, the Seegene Digitalized Development System.

These technologies are designed to enable comprehensive target coverage in a single reaction while maintaining the sensitivity and specificity required for reliable multiplex testing. By integrating these platforms, Seegene USA developed a multiplex real-time PCR assay that supports differential diagnosis of HSV-1, HSV-2, VZV, and MPXV from ulcerative skin lesions.

With this EUA, Seegene USA is positioned to expand its portfolio of locally developed multiplex PCR assays for the U.S. market. The authorization also serves as a model for Seegene’s broader Technology-Sharing Initiative, which supports regional partners in developing and manufacturing multiplex molecular tests tailored to local needs.

As this initiative expands globally, Seegene aims to strengthen local development and manufacturing capabilities and improve preparedness for future outbreaks by enabling access to high-multiplex molecular diagnostics.

“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.”

Terminology and references

1. HSV-1 (Herpes Simplex Virus type 1): The primary virus responsible for oral herpes (cold sores), which typically causes blisters and ulcers around the mouth.

2. HSV-2 (Herpes Simplex Virus type 2): The primary virus responsible for genital herpes, causing painful blisters and ulcers in the genital area.

3. VZV (Varicella-Zoster Virus): The virus that causes chickenpox and shingles.

4. MPXV (Monkeypox virus, Mpox virus): The causative virus of Mpox (formerly known as monkeypox), a viral disease characterized by skin rashes, blisters, and ulcers.

5. Johnson, T., Pineda, S., Kim, B., & Kim, H. (2024, October 9). Detection of HSV, VZV, and MPXV clade I/II in previously negative samples utilizing a multiplex PCR assay [Poster presentation]. Clinical Virology Symposium 2024, Long Beach, CA, United States.

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