US Food and Drug Administration (FDA) has awarded the Emergency Use Authorization (EUA) to Beckman Coulter for its Access SARS-CoV-2 IgG assay. The company has already sent around 400 hospitals, clinics and diagnostics laboratories across the US and has started the distribution of the new test to countries that recognise the FDA EUA and CE Mark.
Luminex Corporation has submitted the request for an EUA from the FDA for its xMAP SARS-CoV-2 Multi-Antigen IgG assay. The assay is expected to offer additional capacity to antibodies in patients who are infected or exposed to Covid-19. The assay can offer results for over 96 samples within three hours and can be operated on all xMAP platforms.
GenMark Diagnostics has announced the availability of the ePlex Respiratory Pathogen 2 (RP2) Panel in the US for commercial distribution and clinical use. The ePlex RP2 Panel is capable of identifying 21 pathogens including the Covid-19 causing SARS-CoV-2 virus and is the first rapid-result multiplex panel test that is available for clinical use.