BDX

BD, CerTest Biotec: Mpox Diagnostic Test Gets FDA's EUA

(RTTNews) - Medical technology company Becton, Dickinson and Co. or BD (BDX) and CerTest Biotec announced Monday emergency use authorization or EUA from the U.S. Food and Drug Administration for a molecular polymerase chain reaction or PCR assay for Mpox virus detection.

The company noted that the VIASURE Monkeypox Virus Real Time PCR Reagents for BD MAX System is now available for BD MAX System users.

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.

Nikos Pavlidis, vice president of Molecular Diagnostics at BD, 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. EUA for the assay enables it to be used for timely diagnosis and may help avert further global spread of the disease."

As with all CerTest assays, the VIASURE Monkeypox Virus PCR Detection assay for the BD MAX System is offered in a lyophilized format. 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.

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