Authorization

New Assay To Detect Monkeypox Virus CerTest VIASURE Now Commercially Available Globally

(RTTNews) - BD (Becton, Dickinson and Company) (BDX), and CerTest Biotec on Monday said their new assay to detect monkeypox virus, CerTest VIASURE, is now commercially available globally, including in the United States, only for research use.

The BD MAX System family is an 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. BD's proprietary BD MAX System open architecture reagent suite has been used to develop the CerTest VIASURE.

BD said it plans to submit a clinical test for monkeypox virus for emergency use authorization (EUA) as soon as possible, based on the guidance issued by the FDA on September 7.
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