LabCorp has been granted Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for the Pixel by LabCorp™ Covid-19 Test Home Collection Kit to be made commercially available without requiring prescription. The approval will allow LabCorp to distribute the at-home kits through retail channels.
Roche and Moderna have announced a partnership to utilise the Elecsys® Anti-SARS-CoV-2 S antibody test in Moderna’s mRNA-1273 vaccine research trials. This will to measure the SARS-CoV-2 antibodies of trial participants to establish a correlation between vaccine-induced protection and anti-receptor binding domain (RBD) antibodies. Roche was recently granted EUA for the Elecsys® antibody test.
Ellume, a digital diagnostics company, has announced that its rapid, at-home Covid-19 antigen test demonstrated 96% accuracy in a US clinical study conducted across five states. The Ellume Covid-19 home test is considered to be easy to use and safe for detecting the SARS-CoV-2 nucleocapsid antigen among those aged two years and above. The rapid self-test delivers results in 15 minutes or less.
ams, a supplier of sensor solutions, and Senova, an in-vitro diagnostic medical devices manufacturer, have announced the opening of a production line for lateral flow tests that will help detect antibodies from the SARS-CoV-2 virus. The cost-effective platform was developed in less than nine months and will process the data in a secure medical cloud.