Seegene USA has obtained Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its syndromic PCR diagnostic product that can simultaneously identify viruses causing skin and mucosal lesions. This approval is significant as it allows for a competitive edge in the market where appropriate treatments are lacking.
On July 21, Seegene announced that its U.S. subsidiary, Seegene USA, received the EUA for the Allplex™ HSV-1&2/VZV/MPXV Assay.
The Allplex HSV-1&2/VZV/MPXV Assay is a real-time syndromic PCR diagnostic product designed to detect multiple viral pathogens that cause similar clinical manifestations in skin and mucosal lesions. Previously, there were products available to diagnose herpes simplex virus (HSV-1, HSV-2), varicella-zoster virus (VZV), and monkeypox virus (MPXV) individually, but none could test for these viruses simultaneously. This integrated diagnostic solution received FDA EUA to enhance diagnostic accuracy and facilitate rapid identification of infection sources.
The product is designed to detect MPXV clades I and II, as well as HSV-1, HSV-2, and VZV in a single test, utilizing Seegene's proprietary syndromic PCR technology. Infections from these viruses often present similar clinical symptoms, such as vesicular or pustular lesions on the skin, making it challenging to distinguish between them with single-pathogen tests alone.
A study presented at the 2024 Clinical Virology Symposium revealed that among 966 samples previously confirmed negative by single-pathogen tests, 54 were found to contain undetected HSV, VZV, or MPXV clades I and II upon reanalysis with multiplex PCR testing. This indicates that single-target tests may miss some infection cases, according to the company.
Notably, this product is the first FDA EUA product capable of detecting both MPXV clades I and II and providing separate confirmation of clade II, offering essential information for patient management and infection control.
Kim Jun-beom, CEO of Seegene USA, stated, "Seegene's syndromic PCR technology is already widely utilized in global markets. This emergency use authorization marks a significant milestone for Seegene USA, allowing for a more robust application of this technology in the U.S. market and laying the groundwork for the development of localized syndromic molecular diagnostic products to support clinical laboratories and public health needs in the United States."
* This article has been translated by AI.
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