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FDA grants EUA for Thermo Fisher monkeypox test

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February 2023—Thermo Fisher Scientific announced the FDA has granted emergency use authorization for its Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA kit, a polymerase chain reaction test designed to detect non-variola orthopoxviruses, including monkeypox virus, in approximately three-and-a-half hours. The test is intended for the qualitative detection of DNA from monkeypox virus (clades one and two) and screening for non-variola orthopoxviruses in human lesion swab specimens from patients suspected of monkeypox infection by their health care provider. The test is for in vitro diagnostic use.

Thermo Fisher Scientific, 781-622-1000

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