FDA Grants Emergency Use Authorization to Labcorp for Home Collection of Mpox PCR Test

Labcorp (NYSE: LH), a leading provider of innovative laboratory services globally, has announced 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 aids in diagnosing infection with non-variola Orthopoxvirus, including the monkeypox virus, also referred to as mpox. This marks the first FDA-authorized at-home collection kit for mpox, and it is available for physicians to order for patients aged 18 and above suspected of mpox infection.

Dr. Brian Caveney, Labcorp’s chief medical and scientific officer, expressed the significance of this FDA authorization: “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.” He emphasized Labcorp’s commitment to providing essential diagnostic tools to physicians and convenient testing options to patients.

Physicians can order the test through Labcorp’s provider interface platform for patients suspected of mpox infection. Labcorp will then dispatch the test kit directly to patients for at-home collection, complete with detailed instructions on swab collection, sample securing, and package preparation for return to an authorized laboratory for analysis.

The testing of collected specimens will utilize PCR technology and will be carried out in authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to meet high-complexity testing criteria for non-variola Orthopoxvirus DNA detection. Results will be electronically transmitted to the prescribing physician and accessible to the patient via Labcorp’s patient portal.

This authorization follows a reported increase in mpox cases in the United States. The Centers for Disease Control and Prevention (CDC) recorded 511 mpox cases in 2024 through March 16, compared to fewer than 300 cases by late March 2023. Since the onset of the 2022-2023 national mpox virus outbreak, part of a broader global outbreak of human mpox caused by the West African clade of the monkeypox virus, the CDC has reported over 32,000 cases and 58 deaths nationally.

For further information, visit Labcorp’s infectious disease webpage at https://www.labcorp.com/infectious-disease/mpox.

It’s important to note that while this product has not been FDA cleared or approved, it has been authorized for emergency use by the FDA under an EUA. This authorization is solely for the collection and maintenance of lesion swab specimens as an aid in detecting nucleic acid from non-variola Orthopoxvirus, including the monkeypox virus, and not for any other viruses or pathogens. The emergency use authorization of this product is only valid for the duration of the declaration justifying the authorization of emergency use of in vitro diagnostics for detecting and diagnosing infection with the monkeypox virus, under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, unless terminated or revoked sooner.

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