Thermo Fisher’s monkeypox test granted emergency use authorization by FDA

Thermo Fisher Scientific announced the U.S. Food and Drug Administration 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 and screening for non-variola Orthopoxviruses in human lesion swab specimens from individuals suspected of monkeypox (mpox) infection by their healthcare provider. The TaqPath Monkeypox/Orthopox Virus DNA Kit is also designed for identification of other non-variola Orthopoxvirus DNA. While positive results are indicative of the presence of DNA from monkeypox virus or other non-variola Orthopoxvirus, clinicians must correlate PCR results with patient history and other diagnostic information to determine infection status.