NEW YORK – Accelerate Diagnostics and BioCheck announced on Tuesday that it has received Emergency Use Authorization from the US Food and Drug Administration for a COVID-19 serology assay and test system.
The BioCheck SARS-CoV-2 IgM and IgG Combo Test and fully-automated MS-Fast instrument will be marketed and commercialized by Accelerate Diagnostics following a commercial supply and collaboration agreement the firms forged in April.
The system is capable of processing serum samples in 30 minutes to detect antibodies that indicate recent or prior COVID-19 infection, the firm said in a statement.
Jack Phillips, CEO of Accelerate Diagnostics, said that the 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," Phillps said. "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," he added.
Amy Zhang, vice president and general manager of San Francisco-based BioCheck said that the 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."
The BioCheck SARS-CoV-2 IgM and IgG Combo Test targets the S1 protein, which is the major antigen of the novel coronavirus. The S1 protein has the fewest similarities to other coronaviruses, which allows for a lower probability of false positives due to cross reactivity, said Shelley Campeau, Accelerate Diagnostics' clinical trials manager. It 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," Campeau said.
Accelerate Diagnostics recently described plans to put additional test menu items on the MS-Fast immunoassay system in the future and is also launching other products to support its legacy rapid antimicrobial susceptibility testing business.