FDA Grants Emergency Use Authorization for Seegene Multiplex PCR Assay Detecting Four Viruses

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Seegene USA for its Allplex multiplex PCR assay. This authorization allows the test to simultaneously detect and differentiate four specific viruses—HSV-1, HSV-2, VZV, and the monkeypox virus—within a single reaction.

The assay functions by identifying the genetic material of these pathogens in one diagnostic process. By providing the ability to distinguish between these viruses in a single test, the technology streamlines the screening process for clinicians. This authorization marks the first time the FDA has approved a U.S.-based test capable of identifying this specific combination of viruses simultaneously.

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Source: GO-AI-ne1

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Date: July 21, 2026

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GOAI