NEW YORK – The US Food and Drug Administration has granted Emergency Use Authorization for Becton Dickinson’s monkeypox PCR test.
The assay, Viasure Monkeypox virus Real-Time PCR Reagents for BD Max System, is designed to qualitatively detect monkeypox virus DNA in human lesion swab samples from individuals suspected of monkeypox infection by their healthcare provider. While positive results are indicative of the presence of monkeypox virus DNA, clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status, the FDA said.
Since September, the FDA has been issuing EUAs for monkeypox tests. So far, Thermo Fisher, Quest Diagnostics, Roche, and Abbott have also nabbed EUAs for their monkeypox assays.