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<![CDATA[FDA Grants Emergency Use Authorization for Seegene’s Multiplex PCR Assay ]]>
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Pharmaceutical Executive articles
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.1 The 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.
HSV-1, HSV-2, VZV and MPXV frequently produce vesicular or pustular lesions that are clinically indistinguishable by appearance alone.
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.”