FDA grants emergency use authorization to first mpox PCR home test

Key takeaways:

• Labcorp has received FDA emergency use authorization for its Mpox PCR Test Home Collection Kit.
• This test is now available for physicians to purchase.

The FDA has granted emergency use authorization for Labcorp’s Mpox PCR Test Home Collection Kit, the company announced in a press release.

The [polymerase chain reaction (PCR)] test kit is the first at-home collection kit authorized by the FDA to aid in the diagnosis of infection with non-variola orthopoxvirus, which includes the mpox virus.

This authorization from the FDA comes amid increasing reports of mpox cases. According to the CDC, there have been 511 mpox cases reported through March 16, a stark uptick from the fewer than 300 cases reported by the same time last year.

To date, the CDC reports there have been more than 32,000 cases of mpox and 58 deaths related to the disease reported nationwide.

“The FDA’s emergency authorization of Labcorp's Mpox PCR Test Home Collection Kit will enable us to play a vital role within the health care community in the early detection and management of mpox,” Brian Caveney, MD, JD, MPH, Labcorp’s chief medical and scientific officer, said in the release.

Physicians can now order this test through Labcorp’s provider interface platform for patients aged 18 years or older who are suspected of mpox infection. The kit includes detailed instructions for patients, including how to prepare the package for return to an authorized laboratory for analysis. Once tested, results will be electronically delivered to the prescribing physician and uploaded to the patient’s Labcorp portal.