Biodesix collaborates with Bio-Rad to launch test to detect COVID-19 antibodies

Wednesday May 20, 2020 0 comments Tags: Boulder, Biodesix, Scott Hutton, COVID-19, Bio-Rad labs

BOULDER -- Biodesix, Inc. announced it has collaborated with California-based Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) to launch a blood-based immunoassay-based test that identifies antibodies to SARS-CoV-2, the virus that causes COVID-19.Biodesix_logoUSE 

The Platelia SARS-CoV-2 Total Ab test was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) late last month, making it the first total antibody test to receive EUA from the FDA.

Clinical evaluation demonstrated specificity greater than 99 percent and diagnostic sensitivity of 98 percent eight days after the onset of symptoms.

Cross-reactivity testing demonstrated specificity of 100 percent with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.

After infection with SARS-CoV-2, viral antigens stimulate the body's adaptive immune system to produce antibodies to fight the virus. The Platelia SARS-CoV-2 Total Ab test identifies if a patient has produced those antibodies.

“The Platelia SARS-CoV-2 Total Ab test helps clinicians determine if a patient has potentially been infected by SARS-CoV-2 and therefore has developed an immune response against the virus,” said Scott Hutton, Biodesix CEO.

“This gives us a more complete understanding of infection rates as well as potential immunity, which will be vital information as we continue working to stop the spread of COVID-19.”

The Platelia SARS-CoV-2 test requires collection of a blood sample, which is sent to the CLIA-certified laboratory in De Soto, Kansas, for processing. Results will be delivered in 24 hours.

Biodesix currently has the capacity to process 14,000 tests a day. The Platelia SARS-CoV-2 Total Antibody test can be utilized in combination with the SARS-CoV-2 Droplet Digital PCR (ddPCR) test to diagnose symptomatic patients and assess immunity in the population.