BD, CerTest Release Monkeypox Assay Globally for Research Labs

BD (Becton Dickinson) and CerTest Biotec have globally released their newly developed molecular PCR assay for monkeypox for research use only in laboratories.
 
The BD MAX system open architecture reagent suite was used to develop the CerTest VIASURE Monkeypox molecular research use only assay. BD aims to submit a clinical monkeypox test for emergency use authorization (EUA) as soon as possible, based on FDA guidance issued September 7.
 
“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,” Nikos Pavlidis, VP of Molecular Diagnostics at BD told the press. “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 integrated, automated platform performs nucleic acid extraction and real-time PCR and provides results for up to 24 samples for multiple syndromes in less than three hours.
 
“This new test boosts capacity for monkeypox research and surveillance of this global health emergency,” said Nelson Fernandes, managing director of CerTest Biotec. “The value of the BD MAX™ open systems architecture and its ability to speed research and development continues to be critical.”
 
CerTest’s VIASURE Monkeypox virus PCR Detection RUO assay for BD MAX is offered in a lyophilized format. Accordingly, the assay will come in a tube that snaps into the test-specific position on the BD MAX ExK TNA extraction strip supplied by BD.