First Commercial Monkeypox Authorized by the U.S. FDA

The U.S. Food and Drug Administration (FDA) recently issued an Emergency Use Authorization (EUA) to Abbott Molecular, Inc., for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens.

Illinois-based Abbott's Alinity m MPXV test is the first commercial test kit to be authorized for the detection of monkeypox in the U.S.

“Today’s actions underscore the FDA’s ongoing commitment to expand access to monkeypox testing. continue to work collaboratively with test developers, labs, and the CDC to encourage novel test development and facilitate access to safe and reliable tests that meet public health needs," commented Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in a media statement issued on October 7, 2022.

Alinity m is a fully integrated and automated molecular diagnostics analyzer intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures, and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 that meet the requirements to perform moderate or high complexity tests.

Other monkeypox outbreak news is posted at Monkeypox Today.