BURLINGTON, N.C. - Labcorp (NYSE: LH), a provider of laboratory services, announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox PCR Test Home Collection Kit. This kit is the first FDA-authorized at-home collection kit for mpox, designed to aid in the diagnosis of non-variola Orthopoxvirus infections, including mpox.
Physicians can now order the kit for patients aged 18 and older who are suspected of having an mpox infection. Labcorp will ship the kit directly to patients, who can then collect a lesion swab sample at home and send it back to Labcorp for analysis. The testing, which utilizes PCR technology, will be conducted in authorized laboratories, with results delivered electronically to the prescribing physician and available to patients via Labcorp's patient portal.
This authorization comes in the wake of an increase in reported mpox cases in the United States. The Centers for Disease Control and Prevention (CDC) has reported 511 cases in 2024 as of March 16, an uptick from the fewer than 300 cases by the same time in 2023. Since the 2022-2023 national outbreak began, over 32,000 cases and 58 deaths have been reported in the U.S.
The Mpox PCR Test Home Collection Kit is authorized for emergency use during the period of the declared public health emergency. It is not FDA cleared or approved but is authorized for lesion swab specimen collection and maintenance as an aid in detecting non-variola Orthopoxvirus nucleic acid.
The information in this article is based on a press release statement.
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