Becton, Dickinson (NYSE:BDX) and partner CerTest Biotec said on Monday their molecular polymerase chain reaction (PCR) assay for monkeypox virus was now commercially available globally, including in the United States, for research use only applications by laboratories.
BD said it was working to submit a clinical test for monkeypox virus for emergency used authorization by the U.S. Food and Drug Administration as soon as possible.
The CerTest Viasure Monkeypox virus PCR Detection RUO assay for the BD MAX System is offered in a lyophilized format.
The BD MAX System is a platform that performs nucleic acid extraction and real-time PCR that provide results for up to 24 samples across multiple syndromes in less than three hours.