Accelerate Diagnostics Announces FDA Emergency Use Authorization for COVID-19 Antibody Testing System

TUCSON, Ariz., Aug. 18, 2020 /PRNewswire/ -- Accelerate Diagnostics, Inc. (NASDAQ: AXDX) and BioCheck, Inc., a privately-held San Francisco-based company 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 fully-automated MS-Fast instrument.

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.

"The BioCheck SARS-CoV-2 IgM and IgG Combo Test targets the S1 protein, which is the major antigen of the novel coronavirus," stated 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."

Jack Phillips, Accelerate Diagnostics' Chief Executive Officer, also commented, "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."

Dr. Amy Zhang, Vice President and General Manager of BioCheck, stated, "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."

About Accelerate Diagnostics, Inc.

Accelerate Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis. The Accelerate Pheno® system and Accelerate PhenoTest® BC kit combine several technologies aimed at reducing the time clinicians must wait to determine the most optimal antibiotic therapy for deadly infections. The FDA cleared system and kit fully automate the sample preparation steps to report phenotypic antibiotic susceptibility results in approximately 7 hours direct from positive blood cultures. Recent external studies indicate the solution offers results 1–2 days faster than existing methods, enabling clinicians to optimize antibiotic selection and dosage specific to the individual patient days earlier.

About BioCheck, Inc.

Since 1997, biotechnology company BioCheck, Inc. has been engaged in the development and manufacturing of high-quality in vitro diagnostic test kits for the worldwide biomedical, pharmaceutical, and scientific research markets under cGMP and ISO 13485 standards. BioCheck is commercializing the MS-FAST analyzer (automated chemiluminescent immunoassay system) and associated Covid-19 and other cytokine, metabolic, and cardiovascular test kits to allow convenient, instant, and accurate diagnosis of disease markers with a bench top instrument. In addition, the company also develops ultra-sensitive assays using Simoa™ technology (single molecule array), a powerful tool for detecting low-abundance biomarkers.