The US Food and Drug Administration (FDA) issued an immediately effective guidance and a corresponding FAQ to spur the development of new monkeypox diagnostics during the public health emergency. The agency said there is a need for new private sector tests, as the only currently cleared diagnostic is one developed by the Centers for Disease Control and Prevention (CDC).
Alongside the announcement, the agency issued the first emergency use authorization (EUA) for a monkeypox test, the Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR, which detects monkeypox and other non-variola orthopoxvirus DNA via lesion swab specimens.
The guidance comes a month after Health and Human Services Secretary Xavier Becerra declared monkeypox a public health emergency. While the disease is not yet endemic in the US, the number of reported cases has topped 21,000 and public health officials have been criticized for not responding more aggressively to stem the disease’s spread.
