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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.