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Thermo Fisher Scientific Receives FDA Emergency Use Authorization for Monkeypox PCR Assay


NEW YORK – Thermo Fisher Scientific said on Wednesday that its monkeypox PCR test has been granted Emergency Use Authorization by the US Food and Drug Administration.

The Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit is designed to detect DNA from the monkeypox virus and screen for non-variola orthopoxviruses in human lesion swab samples from patients suspected of monkeypox infection, according to Thermo Fisher. While positive test results are indicative of the presence of DNA from the monkeypox virus or other non-variola orthopoxviruses, clinicians must correlate PCR results with patient history and other diagnostic information to determine infection status, the company said.

The FDA has been issuing EUAs for monkeypox tests since September. Before Thermo Fisher, Quest Diagnostics, Roche, and Abbott have obtained EUAs for their monkeypox assays.