BD, Certest Biotec Announce US Commercial Launch of Monkeypox Assay



BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Certest Biotec  announced their newly developed molecular polymerase chain reaction (PCR) assay for monkeypox virus is now commercially available globally, including in the United States, for research use only applications by laboratories.

The teams leveraged the BD MAX System open architecture reagent suite to develop the Certest VIASURE Monkeypox molecular research use only assay. BD is working to submit a clinical test for monkeypox virus for emergency used authorization (EUA) as soon as possible, based on the guidance issued by the FDA on 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,” said Nikos Pavlidis, vice president of Molecular Diagnostics at BD.  “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 a fully integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in less than three hours. BD offers an extensive menu of tests on the system covering health care associated infections, respiratory infections, sexually transmitted infections, gastrointestinal infections and women’s health.

“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.”

As with all Certest assays, the Certest VIASURE Monkeypox virus PCR Detection RUO assay for the BD MAX System 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, which is supplied by BD.