BD, CerTest receive emergency use authorization for mpox diagnostic test

BD, a global medtech company, and CerTest Biotec have received emergency use authorization from FDA for their polymerase chain reaction mpox test. 

Users of the BD Max System, an automated platform that allows for nucleic acid extraction and PCR results for up to 24 samples, will now have access to the cleared mpox test, according to a Jan. 9 BD news release.

"The mpox outbreak continues to be designated as a global health emergency — the World Health Organization's highest level of alert," BD Vice President of Molecular Diagnostics Nikos Pavlidis said. "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. Emergency use authorization for the assay enables it to be used for timely diagnosis and may help avert further global spread of the disease."

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