US-based medical technology company BD has received the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for a molecular assay to detect the Mpox virus.
The assay, dubbed VIASURE Monkeypox Virus Real Time PCR Reagents for BD MAX System, was developed in partnership with Spanish biotechnology company CerTest Biotec.
BD MAX System is a fully integrated, automated assay platform that facilitates nucleic acid extraction and PCR testing in real time.
The test is designed to detect up to 24 samples across multiple syndromes, and provide the test results in less than three hours, said BD.
Similar to all other CerTest assays, the VIASURE Monkeypox Virus PCR Detection assay for the BD MAX System is also offered in a lyophilised format.
The assay comes in a tube that fits into the test-specific position on the BD MAX ExK TNA extraction strip, which is supplied by BD.
Last year, BD and CerTest Biotec commercially launched the monkeypox virus test for research use only (RUO) applications by laboratories in the US and global markets.
BD molecular diagnostics vice president Nikos Pavlidis said: “The large installed base of the BD MAX System in hospital labs provides broad access to testing for a wide range of infectious diseases, now including the Mpox virus.
“EUA for the assay enables it to be used for timely diagnosis and may help avert the further global spread of the disease.”
CerTest Biotec managing director Nelson Fernandes said: “The EUA for the assay enables use for clinical diagnosis of the disease, in addition to surveillance and the research and development of vaccines and treatments.”
In 2021, the two companies secured the CE mark for their Covid-19 molecular test, dubbed VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit for BD MAX System
The test was designed to detect and distinguish between the Alpha (B.1.1.7), Beta (B.1.351) and Gamma (P.1) SARS-CoV-2 variants.
VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit for BD MAX can be used together with VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for BD MAX.
