News|Articles|July 21, 2026

FDA Grants Emergency Use Authorization for Seegene’s Multiplex PCR Assay

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Key Takeaways

EUA marks the first U.S. multiplex PCR capable of differential detection of HSV-1, HSV-2, VZV, and MPXV from a single specimen.
Overlapping lesion morphology makes sequential single-pathogen testing unreliable, creating risk of delayed antivirals, inappropriate isolation decisions, and missed public-health reporting for MPXV.
Retesting 966 prior negatives with multiplex PCR yielded 54 additional detections, including HSV, VZV, and MPXV clades I/II, underscoring false-negative gaps in narrow assays.
Assay development leveraged DPO, TOCE, and MuDT with automated design workflows, extending an earlier 510(k)-cleared Anyplex II HSV-1/2 performance profile into broader syndromic coverage.

FDA has granted Emergency Use Authorization to Seegene USA's Allplex multiplex PCR assay, making it the first U.S.-authorized test to simultaneously detect and differentiate HSV-1, HSV-2, VZV, and monkeypox virus in a single reaction.

Seegene USA, the U.S. subsidiary of molecular diagnostics company Seegene, received Emergency Use Authorization (EUA) from FDA for the Allplex HSV-1&2/VZV/MPXV Assay.

The multiplex real-time PCR test is capable of simultaneously detecting herpes simplex virus type 1 and type 2, varicella-zoster virus (VZV) and monkeypox virus (MPXV) in a single reaction.¹The assay is the first multiplex PCR test authorized in the U.S. to concurrently and differentially detect all four viral pathogens associated with overlapping ulcerative skin lesion presentations.

With the EUA secured, Seegene USA is positioned to expand its portfolio of locally developed multiplex PCR assays for the U.S. market, building on the company's established regulatory footprint and moving beyond its initial HSV-focused clearance into broader syndromic testing.¹

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Why does simultaneous detection matter?

HSV-1, HSV-2, VZV and MPXV frequently produce vesicular or pustular lesions that are clinically indistinguishable by appearance alone. When clinicians test for only one pathogen at a time, infections caused by untested viruses can go undiagnosed, a meaningful gap with real patient consequences.

Data presented in a poster at the 2024 Clinical Virology Symposium illustrated the scale of this problem, specifically when scientists applied a multiplex PCR assay to samples that had previously returned negative results using single-pathogen methods, the multiplex test identified HSV, VZV or MPXV clade I or II in 54 out of 966 of those samples, cases that single-target testing had missed entirely.¹

How does the assay work?

The Allplex HSV-1&2/VZV/MPXV Assay was developed end-to-end at Seegene USA using the company's proprietary high-multiplex PCR technologies: Dual Priming Oligonucleotide, Tagging Oligonucleotide Cleavage and Extension, and Multiple Detection Temperatures, along with its automated product development platform.¹ These technologies enable comprehensive target coverage within a single reaction while maintaining the sensitivity and specificity required for reliable multiplex diagnostic testing.¹

What is Seegene's prior regulatory track record in HSV diagnostics?

The EUA builds on Seegene's established history with FDA-cleared HSV diagnostics in the U.S. The company received its first-ever FDA clearance, a 510(k), for its Anyplex II HSV-1/2 Assay, a two-target real-time PCR test for the qualitative detection and differentiation of HSV-1 and HSV-2 from female anogenital lesions, which marked Seegene's initial entry into the U.S. market.²

Following the initial FDA clearance, Jong-Yoon Chun, PhD, founder, CTO, and CEO of Seegene noted the importance, saying:“This is an important milestone in support of our planned entry into the United States, the largest molecular diagnostic market in the world. After more than 10 years of extensive efforts to continually develop and commercialize novel technologies to surpass the capabilities of real-time PCR, we successfully invented MuDT technology, an ultimate multiplex real-time PCR technology that marks a new era in the molecular diagnostics industry. Through FDA approval, Seegene now intends to actively enhance its leadership in the multiplex real-time PCR diagnostic testing market.”

In a multi-center clinical evaluation of 656 prospective specimens across three U.S. sites, that assay demonstrated sensitivity of 98.9% and specificity of 93.7% for HSV-1, and sensitivity of 97.2% and specificity of 93.6% for HSV-2.² The new Allplex assay expands significantly on that cleared platform, adding VZV and MPXV detection in a single reaction, addressing the diagnostic gaps that a two-pathogen assay cannot resolve when lesion presentations clinically overlap.¹

Sources

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 Seegene Inc. July 21, 2026 https://www.prnewswire.com/news-releases/seegene-usa-receives-fda-emergency-use-authorization-for-multiplex-pcr-assay-advancing-differential-diagnosis-of-hsv-12-vzv-and-monkeypox-virus-for-ulcerative-skin-lesions-302830847.html
FDA Approves Seegene HSV 1 and 2 Assay Clinical Lab Products February 23, 2015 https://clpmag.com/diagnostic-technologies/molecular-diagnostics/fda-approves-seegene-hsv-1-2-assay/

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