Life Sciences Insight

Accelerate Diagnostics and BioCheck gain FDA Emergency Use Authorization for COVID-19 Test Kits

In collaboration with BioCheck, Accelerate Diagnostics announced yesterday that the US Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for BioCheck’s SARS-CoV-2 IgM & SARS-CoV-2 IgC Test Kits.

Biocheck’s SARS-CoV-2 IgM and IgG Antibody Test Kits detect the SARS-CoV-2 IgM and IgG antibodies in human serum using chemiluminescent immunoassays. The test kits give results of COVID-19 anitbodies in roughly 30 minutes.

Accelerate Diagnostics will commercialize and market the test kits.

Statement from Accelerate Diagnostics CEO

CEO Jack Phillips of Accelerate Diagnostics stated: “Offering the individual BioCheck SARS-CoV-2 IgM and IgG tests alongside the BioCheck SARS-CoV-2 IgM and IgG Combo Test will provide our customers with the flexibility to meet their specific testing needs. We’re tremendously excited to offer this accurate, high-quality antibody testing technology to our customers, as we believe the adoption of serology-based COVID-19 antibody testing will be an increasingly important tool in the fight against COVID-19.”

About Accelerate Diagnostics:

Accelerate Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions for the global challenge of antibiotic resistance and hospital acquired infections. Established in 1987, the company began research activity for microbiology solutions in 2004 and relaunched in 2012 as Accelerate Diagnostics, Inc. to develop and commercialize its first diagnostic platform.

About Biocheck

BioCheck, located in the San Francisco Bay Area, was founded in April 1997, to develop and manufacture high-quality enzyme immunoassay test kits for the worldwide biomedical, pharmaceutical and scientific research markets. The founders have brought over four decades of experience, enabling BioCheck to quickly provide reliable and sensitive products to its customers.