Labcorp, a lab services company based in North Carolina, today announced that the US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for its PCR Test Home Collection Kit for mpox, the first at-home sample collection kit of its kind for the virus.
In a statement, the company said the test is available for physicians to order for use in adults who have suspected mpox infections.
Brian Caveney, MD, JD, MPH, Labcorp's chief medical and scientific officer, said the EUA authorization allows the company to play a key role in early detection and management of mpox. "The collection kit reflects our ongoing commitment to providing critical diagnostic tools to physicians and accessible and convenient testing options to patients."
Available via physician order
Doctors order the test through Labcorp's provider interface, and the company sends the testing kit to the patient's home. The kit contains detailed instruction on how to correctly collect a lesion swab, secure the sample in the collection tube, and prepare the package for return to the lab.
Testing is done by Labcorp-authorized labs, with results delivered to the prescribing physician and made available to the patient through the company's patient portal.
The FDA's EUA for the test comes as US mpox cases outpace activity reported last year at this time. So far, 664 cases have been reported this year as of the week ending March 30, more than double the 307 cases reported during the same period last year, according to the latest data from the Centers for Disease Control and Prevention.