Sophonix announces FDA Emergency Use Authorization
Sophonix, partnering with BioCheck Inc., a privately-held San Francisco-based compnay focused on in vitro diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the BioCheck SARS-Cov-2 IgM and IgG Combo Test and Sophonix fully-automated MS-Fast instrument.
The Sophonix MS-Fast system and BioCheck SARS-CoV-2 chemiluminescence tests are capcable of processing human serum samples in 30 minutes to detect antibodies that indicate recent or prior COVID-19 infection.
Serology testing is an important tool in the fight against COVID-19, as it enables the demographic and geographic surveillance necessary to guide an appropriate response to the COVID-19 pandemic. Through our partnership with BioCheck. we believe that Sophonix MS-Fast instrument and BioCheck SARS-CoV-2 IgG and IgM Combo Test will provide a fast and reliable platform for COVID-19 serology testing across the globe.
For further information：