Becton, Dickinson and Company (BD) and CerTest Biotec have commercially launched their new molecular polymerase chain reaction (PCR) assay for the monkeypox virus for the US and global markets.
According to BD, the PCR assay is available only for research use only (RUO) applications by laboratories.
The CerTest VIASURE Monkeypox molecular assay has been developed by making use of the BD MAX System open architecture reagent suite.
Based on the guidance of the US Food and Drug Administration (FDA), BD is said to be working to submit a clinical test for the monkeypox virus for emergency use authorisation (EUA) as early as possible.
BD molecular diagnostics vice president Nikos Pavlidis said: “Even before the U.S. Department of Health and Human Services and Food and Drug Administration declared the ongoing monkeypox outbreak in the United States a public health emergency, we were working with CerTest to quickly develop a molecular assay to help better understand and track the disease.
“Due to the COVID-19 pandemic, the installed base of our BD MAX System experienced explosive growth, providing greater access to this unique, open-architecture system that enables rapid response to emerging health threats like monkeypox.”
The BD MAX System family is said to be a fully integrated, automated platform. It is designed to carry out nucleic acid extraction and real-time PCR.
The platform is capable of providing results for up to 24 samples across various syndromes within three hours, said BD.
CerTest Biotec managing director Nelson Fernandes said: “This new test boosts capacity for monkeypox research and surveillance of this global health emergency.
“The value of the BD MAX open systems architecture and its ability to speed research and development continues to be critical.”
BD said that the CerTest VIASURE Monkeypox virus PCR Detection RUO test for the BD MAX System is available in a lyophilised format. The assay will be accordingly packaged in a tube that can be placed in the test-specific location on the BD MAX ExK TNA extraction strip.
