FDA Grants Emergency Use Authorization for Monkeypox Viral Diagnostic

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to the VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System.

The real-time PCR diagnostic is intended for the qualitative detection of monkeypox (mpox) virus DNA in human swab lesion specimens.

In a response letter to Becton, Dickinson & Company (BD), the FDA said the diagnostic would be issued an EUA in light of the Department of Health and Human Services (HSS) previously declaring mpox a public health emergency on August 9, 2022.

On September 7, 2022, the Secretary of HSS declared there are circumstances justifying Emergency Use Authorization for in vitro diagnostics that can detect and/or diagnose mpox viral infection. Notably, emergency use of the test is limited to authorized laboratories.

FDA Senior Regulatory Affairs Manager Melissa Barhoover wrote that the VIASURE mpox diagnostic met all criteria for issuance of an EUA. Barhoover noted that monkeypox can cause severe or life-threatening illness, and “There is no adequate, approved, and available alternative to the emergency use of [the] product.”

Mpox is a zoonotic Orthopoxvirus, part of the smallpox family. It causes a painful, blister-like rash, and is spread primarily through skin-to-skin contact. The US declared monkeypox a national public health emergency on August 4, 2022.

Fortunately, mpox never caused the widescale outbreaks anticipated when the virus began to spread to nonendemic areas over the summer of 2022. After the global explosion of COVID-19, another zoonotic virus, public health officials were careful to contain mpox. The rollout of previously stockpiled smallpox vaccines was an especially fortuitous at preventing mpox in exposed individuals and high-risk populations.

In November, the World Health Organization (WHO), announced the name “monkeypox” would be changed to “mpox,” though both names will be used simultaneously for the next year until “monkeypox” is phased out.

The name change comes at the request of many experts, and is intended to eradicate some of the stigma associated with the original name. “Monkeypox” is also a bit of a misnomer, as its animal reservoir is not monkeys but rather small rodents in endemic regions of Central and West Africa.

Click here for our full history of monkeypox (mpox) coverage.