Abbott Gets First Monkeypox Test EUA For Commercial Use
The US Food and Drug Administration has granted Abbott emergency use authorization for its monkeypox test, making it the first diagnostic to detect the virus to become commercially available.
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The test, which is the first for the condition to win an EUA using actual patient samples, provides results in about three and a half hours.
FDA Publishes Final Guidance For Developers Seeking EUAs For Monkeypox Tests, Grants First Approval To Quest
The US FDA has issued guidance on its current thinking on enforcement policies for EUAs on monkeypox diagnostics, along with recommendations to help developers get their tests approved more quickly.
The Centers for Disease Control and Prevention (CDC) is providing the non-variola orthopoxvirus test throughout its public health Laboratory Response Network. The diagnostic is currently the only FDA-cleared test to detect monkeypox.