Monkeypox Assay Granted Emergency Use Authorization

Thermo Fisher Scientific’s Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit, a polymerase chain reaction (PCR) test designed to detect non-variola Orthopoxviruses, including monkeypox virus, in approximately three-and-a-half hours, has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).

The test is intended for the qualitative detection of DNA from monkeypox virus (clade I/II) 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.

“Ensuring that all US laboratories have access to monkeypox PCR testing is a critical part of the response to this public health emergency,” said Manoj Gandhi, Senior Medical Director for Genetic Testing Solutions, Thermo Fisher Scientific. “This helps expedite availability of results so that patients can receive the appropriate treatment quickly. Authorised testing also enables public health agencies to stay one step ahead of the virus by monitoring viral spread and addressing affected populations accordingly.”

In early 2020, Thermo Fisher was among the first companies to distribute an emergency use authorised assay to identify active SARS-CoV-2 infections with the TaqPath COVID-19 Combo Kit. The TaqPath Monkeypox/Orthopox Virus DNA Kit builds off that technology and reflects Thermo Fisher’s continued commitment to develop diagnostic tools designed to address pressing public health emergencies as soon as possible.

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