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Labcorp Receives FDA Emergency Use Authorization for Mpox Test Home Collection Kit

NEW YORK – Laboratory Corporation of America said Wednesday that it has received US Food and Drug Administration Emergency Use Authorization for its Mpox PCR Test Home Collection Kit.

The kit, which is the first mpox home collection kit authorized by FDA, it meant for collection of specimens via lesion swab in patients 18 years or older who are suspected of mpox infection.

The collected specimens will be analyzed using Labcorp's  PCR test for mpox, which can be conducted in Labcorp facilities certified under CLIA for high-complexity testing. Results from the test are delivered to the prescribing physician and made available to the patient via Labcorp's patient portal.

Labcorp also plans to make the test available on its Labcorp OnDemand platform.

"The FDA's emergency authorization of Labcorp's Mpox PCR Test Home Collection Kit will enable us to play a vital role within the healthcare community in the early detection and management of mpox," Brian Caveney, Labcorp's chief medical and scientific officer, said in a statement. "The collection kit reflects our ongoing commitment to providing critical diagnostic tools to physicians and accessible and convenient testing options to patients."