Ortho Clinical Diagnostics has announced that its new VITROS Anti-SARS-CoV-2 Total 2 antibody assay and VITROS Anti-SARS-CoV-2 IgG 2 antibody assay have received the CE Mark for qualitative and semi-quantitative detection of Covid-19 antibodies. The antibodies can be acquired manually or through vaccination.
Talis Biomedical Corporation has withdrawn its current application for emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Talis One Covid-19 test in a clinical laboratory improvement amendments (CLIA) moderate setting. The company looks to focus on its planned EUA application in the CLIA waived setting.
Avacta Group, a developer of cancer therapies and diagnostics, has announced that its AffiDX SARS-CoV-2 rapid antigen lateral flow test is capable of detecting the dominant new Covid-19 variants, also known as the B117, or Kent variant, and the D614G variant, along with the original strain. The D614G variant, which appeared earlier on during the pandemic became a dominant strain globally.