Molecular diagnostic company Mobidiag has received emergency use authorization from Finland for its Novodiag Covid-19 molecular diagnostic test. It is a rapid and fully automated test to identify the presence of the SARS-CoV-2 virus, which causes Covid-19. The company is in the process to receive emergency use authorization in Sweden, UK and France.
ZEUS Scientific has submitted its rapid, in vitro Covid-19 diagnostic test for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA). The application is currently under review and the company expects the test to be shipped to customers early next month after receiving the approval. The test is used to detect the presence of IgG and/or IgM antibodies related to the SARS-CoV-2 virus. The lateral flow test of Zeus uses serum, plasma or whole blood from the patient and gives results in 15 minutes.
Quidel Corporation has applied for the FDA’s EUA for its Lyra Direct SARS-CoV-2 Assay to permit direct sample processing. The assay will be run on the same six different instruments as the Lyra SARS-CoV-2 Assay, claimed the firm. The assay does not need an upfront sample extraction. It uses a reformulated buffer that utilises a ten-minute heat step replacing the extraction step, which reduces the processing time by around 50 minutes.
LivaNova has announced that many of its cardiopulmonary products have received approval to be used for Extracorporeal Membrane Oxygenation (ECMO) therapy for more than six hours. As per the approval, which was granted on 6 April, the devices will have to be used as per the FDA’s guidance. This move is expected to increase the availability of devices to help tackle the Covid-19 pandemic.