Accelerate Diagnostics Announces FDA Emergency Use Authorization for COVID-19 Individual IgM and IgG Antibody Tests
Sep 10, 2020
Accelerate Diagnostics and BioCheck, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the individual BioCheck SARS-CoV-2 IgM Test Kit and the BioCheck SARS-CoV-2 IgG Test Kit. Today’s announcement follows the recent EUA approval of the fully automated MS-Fast instrument and the BioCheck SARS-CoV-2 IgM and IgG Combo Test.
In accordance with the previously disclosed commercial supply and collaboration agreement, Accelerate Diagnostics will market, commercialize, and support this serology-based testing platform. The MS-Fast system and BioCheck SARS-CoV-2 chemiluminescence tests are capable of processing human serum samples in 30 minutes to detect antibodies that indicate recent or prior COVID-19 infection.
Read the full press release here.