Accelerate Diagnostics (NSDQ:AXDX) and BioCheck announced that they received FDA emergency use authorization for their COVID-19 antibody test.
The BioCheck SARS-CoV-2 IgM and IgG combo test and fully-automated MS-Fast instrument that received authorization can process human serum samples in 30 minutes to detect antibodies that indicate recent or prior COVID-19 infection, according to a news release.
BioCheck’s test targets the S1 protein, the major antigen of the novel coronavirus and the protein that the company believes allows for lower probability of false positives due to its lack of similarities to other coronaviruses. According to the companies, other tests that received EUA target the nucleocapsid protein, but they believe the S1 antibodies are more likely to protect against infection.
Accelerate Diagnostics will market, commercialize and support BioCheck’s serology-based testing platform through a previously announced commercial supply and collaboration agreement.
“This EUA will allow for more widespread adoption of the MS-Fast serology-based COVID-19 antibody testing platform,” Accelerate Diagnostics CEO Jack Phillips said in the release. “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.”