Global medical technology company Becton Dickinson (BD) and in vitro diagnostic medical devices developer CerTest on Monday announced the commercial launch of a research-use-only PCR assay to detect the monkeypox virus for U.S. and global markets.
The companies used the BD Max System open-architecture reagent suite to develop the CerTest Viasure Monkeypox molecular assay. The assay comes in a lyophilized format and in the form of a tube that snaps into the test-specific position on the BD Max ExK TNA extraction strip supplied by BD, the companies said.
"This new test boosts capacity for monkeypox research and surveillance of this global health emergency," Nelson Fernandes, managing director of CerTest Biotec, said in a statement.
BD said it is working to submit an application for emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a clinical test for monkeypox virus as soon as possible, based on the guidance issued by the agency on September 7.
The BD Max System 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.