NEW YORK ─ The US Food and Drug Administration on Monday granted Emergency Use Authorizations to Siemens Healthineers for its total antibody test to detect the presence of SARS-CoV-2 antibodies running on the firm's Dimension Vista and Dimension EXL analyzers.
The Dimension Vista SARS-CoV-2 total antibody assay and Dimension EXL SARS-CoV-2 total antibody assay received EUA to identify people with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Both are sandwich-based chemiluminescent immunoassays.
Siemens Healthineers had been developing the total antibody assay for use on its Dimension analyzers alongside its development for use with the firm's Advia Centaur and Atellica analyzers.
At the end of May, the FDA had granted two EUAs for the company's laboratory-based total antibody test ─ one for its use on its Advia Centaur XP and Advia Centaur XPT systems and the second for use on its Atellica next-generation system.
Separately on Monday, the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority announced that it has awarded $602,275 to the Erlangen, Germany-based firm for the continued development of its SARS-CoV-2 total antibody test.
Siemens Healthineers has an installed base of greater than 20,000 of the different types of instruments that can run its antibody serology tests for SARS-CoV-2, and 6,000 of them are in North America.