Thermo Fisher Scientific has received emergency use authorization (EUA) for its Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit from the US Food and Drug Administration (FDA).
The polymerase chain reaction (PCR) test has been designed for detecting non-variola Orthopox viruses, including the monkeypox virus, in nearly three-and-a-half hours.
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It is developed to detect DNA from the monkeypox virus (clade I/II) and screen for non-variola Orthopoxviruses in human lesion swab samples collected from people suspected of monkeypox infection.
The company stated that positive test results indicate the presence of DNA from the monkeypox virus or other non-variola orthopoxviruses.
Clinicians need to correlate PCR results with patient history, as well as other diagnostic data for determining the status of the infection.
Thermo Fisher Scientific Genetic Testing Solutions senior medical director Manoj Gandhi said: “Ensuring that all US laboratories have access to monkeypox PCR testing is a critical part of the response to this public health emergency.
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By GlobalData“This helps expedite the 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 the viral spread and addressing affected populations accordingly.”
The regulatory approval of the TaqPath Monkeypox/Orthopox Virus DNA Kit reflects the company’s commitment to developing diagnostic tools to address the demanding public health emergencies as early as possible.
Last month, Thermo Fisher Scientific signed a definitive agreement to buy global speciality diagnostics company, The Binding Site Group, in a cash transaction valued at $2.6bn.
The Binding Site Group is engaged in the research, development, manufacture as well as distribution of assays used for detecting cancers and immune disorders.
