The VIASURE PCR diagnostic is now available under Emergency Use Authorization in laboratories for persons with a suspected mpox infection.
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
In a
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
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
In November, the World Health Organization (WHO),
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.
