Research & Development
Genalyte awarded FDA's EUA for rapid COVID-19 antibody test
16 October 2020 -

Healthcare analytics and diagnostics company Genalyte reported on Thursday the receipt of the US FDA's Emergency Use Authorization (EUA) for its SARS-CoV-2 Multi-Antigen Serology Panel, which tests for IgG and IgM antibodies the body produces in response to COVID-19.

The company said that its multi-antigen serology panel and the FDA-cleared Maverick Diagnostic System will further expand nationwide antibody testing, delivering central, lab-quality results in 20 minutes at point-of-care locations.

Genalyte's SARS-CoV-2 Multi-Antigen Serology Panel tests for IgM and IgG antibodies against 13 unique viral antigens. IgG antibodies, in particular, remain long after a person has recovered and are believed to be a marker of sustained immunity.

Using a machine learning approach, the panel virtually eliminates false positives, achieving 98% specificity and 96% sensitivity.



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