On Apr. 13, 2020, BD (Becton, Dickinson) announced the U.S. Food and Drug Administration (FDA) had granted Emergency Use Authorization (EUA) for an additional molecular diagnostic test for COVID-19 that can return results in two to three hours. The new test also has been CE marked to the IVD Directive (98/79/EC).

The test is in addition to the other tests already available on the BD MAX System from collaborations with BioGX and CerTest and is based on the CDC assay design. The BD MAX System, a molecular diagnostic platform, is already in use at thousands of laboratories worldwide, and each unit is capable of analyzing hundreds of samples over a 24-hour period.