Labcorp Says FDA Grants EUA For Mpox PCR Test Home Collection Kit
(RTTNews) - Laboratory services provider Labcorp (LH) announced Wednesday the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox PCR Test Home Collection Kit.
The kit helps in the diagnosis of infection with non-variola Orthopoxvirus, including the monkeypox virus that causes monkeypox, also known as mpox.
The test is the first mpox at-home collection kit authorized by FDA and is available to physicians to order for patients 18 years of age or older who are suspected of mpox infection.
Physicians can order a test through Labcorp's provider interface platform for patients they suspect may be infected with the virus. Labcorp will send the test kit directly to patients for at-home collection.
The kit includes detailed instructions for patients on correctly collecting a lesion swab, securing the sample in the provided collection tube, and preparing the package for return to an authorized laboratory for analysis.
The results are electronically delivered to the prescribing physician and made available to the patient in Labcorp's patient portal at patient.labcorp.com. The company also aims to make the test available on its Labcorp OnDemand platform.
The authorization comes amid reported increases in mpox cases in the United States. This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA.
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