Accelerate Diagnostics’ COVID-19 Antibody Testing System Granted FDA Emergency Use Authorization

Accelerate Diagnostics, Inc. (Tucson, AZ, USA) and BioCheck, Inc. (San Francisco, CA, USA) have been issued an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the BioCheck SARS-CoV-2 IgM and IgG Combo Test and fully-automated MS-Fast instrument.

The BioCheck SARS-CoV-2 Combo Test Kit contains chemiluminescent immunoassays that qualitatively detect the content of SARS-CoV-2 IgM and IgG antibodies in human serum samples performed on the Sophonix MS-Fast Automated Chemiluminescent Immunoassay Analyzing System. 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. As per their commercial supply and collaboration agreement, Accelerate Diagnostics will market, commercialize, and support this serology-based testing platform.

"The BioCheck SARS-CoV-2 IgM and IgG Combo Test targets the S1 protein, which is the major antigen of the novel coronavirus," said Shelley Campeau, Accelerate Diagnostics' Clinical Trials Manager. "The S1 protein has the fewest similarities to other coronaviruses, which allows for a lower probability of false positives due to cross reactivity. The S1 protein is also the primary target for the leading COVID-19 vaccines candidates, which are being developed to neutralize antibodies that can block the virus from infecting healthy cells. Several other EUA approved tests target the nucleocapsid (N) protein, but we believe the S1 protein antibodies are more likely to be protective against infection and are thus a more clinically relevant marker."

"This EUA will allow for more widespread adoption of the MS-Fast serology-based COVID-19 antibody testing platform. 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 current pandemic. Today's announcement represents the next phase of our commercialization efforts to make a simple-to-use, scalable platform for COVID-19 serology testing available to all laboratories," added Jack Phillips, Accelerate Diagnostics' Chief Executive Officer.

"This EUA is a strong testament to the performance of our tests. Through our partnership with Accelerate Diagnostics, we believe that the MS-Fast instrument and BioCheck SARS-CoV-2 IgM and IgG Combo Test will provide a fast and reliable platform for COVID-19 serology testing across the globe," said Dr. Amy Zhang, Vice President and General Manager of BioCheck.

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Accelerate Diagnostics, Inc.
BioCheck, Inc.