FDA issues Emergency Use Authorisation for BD and CerTest Biotec’s Monkeypox PCR test

pharmafile | January 10, 2023 | News story | Medical Communications  

US medical technology company BD and Spanish biotechnology company CerTest Biotec have joined forces to develop a real-time Monkeypox test which has now been awarded FDA Emergency Use Authorisation (EUA).

 

The molecular assay, named VIASURE Monkeypox Virus Real Time PCR Reagents for BD MAX System, is a fully integrated, automated assay platform that facilitates nucleic acid extraction and PCR testing in real time. It is designed to detect up to 24 samples across multiple syndromes and provide the results in less than 3 hours.

 

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.”

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CerTest Biotec managing director Nelson Fernandes further commented: “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.”

 

BD and CerTest Biotec were initially launched the test for Research Use Only (RUO) last year, across the US and global markets. This test follows the companies’ COVID-19 PCR test ‒ named VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit for BD MAX System ‒ which was awarded the CE mark in 2021.

 

James Spargo


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