FDA Grants EUA to Quest Diagnostics for Monkeypox PCR Test

The FDA has issued an Emergency Use Authorization (EUA) to Quest Diagnostics for its Monkeypox Virus Qualitative Real-Time PCR test.

Specifically, the EUA is for the qualitative detection of DNA from monkeypox virus (West African clade; clade II) and non-variola Orthopoxvirus in lesion swab specimens (swabs of acute pustular or vesicular rash) in universal viral transport media from individuals suspected of having monkeypox virus infection by their healthcare provider.

Although an FDA-cleared test exists for the qualitative detection of non-variola Orthopoxvirus, including the monkeypox virus, the agency said that product is not an adequate and available alternative to Quest Diagnostics’ product.

Only authorized laboratories are permitted under the EUA to perform tests related to the product, said FDA.