Monkeypox: FDA issues EUA For New Test

The US Food and Drug Administration (FDA) late Wednesday announced a series of actions to increase access to monkeypox testing.

Regulators issued an Emergency Use Authorization (EUA) for a real-time PCR test from Quest Diagnostics.

The agency also issued guidelines on its plans to prioritize review of EUA requests for all monkeypox in vitro testing. The announcement included a series of templates test developers could voluntarily use to validate their tests before submitting them for EUAs.

“The agency’s intent is to facilitate the development of additional tests to address local availability and accessibility concerns not addressed by current testing capabilities,” a news release announcing the new policies stated. “The FDA will monitor the situation and may adjust its policies as appropriate to address testing needs.”

Expanded testing could help curb the spread of the virus, as asymptomatic cases have sprouted, and experts suspect that infected patients can transmit the virus before a rash develops.

On August 9, 2022, the FDA also issued an EUA for the JYNNEOS vaccine to be used intradermally for high-risk adult patients.

Robert Finn is an Executive Editor at Medscape Medical News.

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