BD (NYSE:BDX) and CerTest Biotec announced today that their monkeypox diagnostic received FDA emergency use authorization (EUA).
Franklin Lakes, New Jersey-based BD and Zaragoza, Spain-based CerTest announced a partnership to develop the test in June. The Viasure monkeypox (Mpox) virus real-time PCR assay works with the BD Max system.
The automated platform, performs nucleic acid extraction and real-time PCR testing. It provides results for up to 24 samples across multiple syndromes in less than three hours, the company said.
The companies made the diagnostic available outside of the U.S. for use in research applications by laboratories in July. They went on to launch it for lab research in the U.S. in September.
“The Mpox outbreak continues to be designated as a global health emergency — the World Health Organization’s highest level of alert,” said Nikos Pavlidis, VP of molecular diagnostics at BD. “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 further global spread of the disease.”
The companies plan to offer Viasure in a lyophilized format. The assay comes into a tube that snaps into a test-specific position on the BD Max ExK TNA extraction strip.
“We were able to quickly develop the Viasure mpox molecular test by leveraging the BD Max system’s open system reagent suite,” said Nelson Fernandes, managing director of CerTest Biotec. “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.”
