US FDA grants EUA for BD and CerTest’s PCR test to detect Mpox

Original from: Medical Device Network

Becton, Dickinson and Company (BD) and CerTest Biotec have announced that their molecular assay for detecting the Mpox virus has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).

Dubbed VIASURE Monkeypox Virus Real-Time PCR Reagents assay, it works with the BD Max system.

It has been designed for the qualitative detection of Monkeypox virus DNA in serum, vesicle/cutaneous-skin fluid, fluid from wounds and swab wound from people who are suspected of infection by their healthcare provider.

The BD MAX System is a completely integrated, automated assay platform that performs nucleic acid extraction and real-time polymerase chain reaction (PCR) testing.        

It provides results for up to 24 samples across several syndromes in under three hours.

The VIASURE Monkeypox Virus PCR Detection assay for the BD MAX System is also offered in a lyophilised format, similar to other CerTest assays.

It comes in a tube that fits in the test-specific position on the BD MAX ExK TNA extraction strip supplied by BD.

BD Molecular Diagnostics vice-president Nikos Pavlidis said: “The Mpox outbreak continues to be designated as a global health emergency – the World Health Organisation’s highest level of alert. 

“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 further global spread of the disease.”

Last year, the companies announced the commercial launch of the assay for research use only (RUO) applications by laboratories in the US as well as global markets.

Source: US FDA grants EUA for BD and CerTest’s PCR test to detect Mpox