BOULDER — Biodesix Inc. and development partner Bio-Rad Laboratories Inc. (NYSE: BIO) are preparing to launch a test to determine if someone had previously been infected with the COVID-19 virus and fought it off without requiring critical care.
The companies received an emergency use authorization for the tests late last month from the U.S. Food and Drug Administration, becoming one of only a handful of more than 120 tests on the market today to get some level of regulatory approval.
“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,” Biodesix CEO Scott Hutton said in a statement.
Antibody tests are considered critical tools for surveilling the spread of coronavirus across populations and have been proposed as a way to determine who may be able to return to in-person work or gatherings because their bodies have developed immunity to COVID after showing mild symptoms or no symptoms at all.
However, medical researchers have warned that it’s not known how long that natural immunity to COVID may last, and it’s not clear how reliable many of the antibody tests are based on how long it takes for antibodies to develop.
In a preliminary working paper, researchers at the University of California-San Francisco tested the kits against confirmed positive samples. Those results, which have not been peer-reviewed, show the accuracy of the tests were between 80% to 100% accurate when the sample was taken 20 days after initial symptoms manifested, while about 15% of tests on confirmed negative samples returned false positives for antibodies.
Biodesix and Bio-Rad claim that for patients who are eight days past the initial onset of symptoms, the tests have 98% sensitivity, a measure of how likely it will detect the presence of an antibody, and 99% specificity, the measure of how likely it is to accurately determine if someone was positive or negative. A higher specificity rate means a lower chance of a false positive.
Biodesix mainly develops genetic tests for lung cancers but has since partnered with Bio-Rad to develop a rapid COVID test and process up to 1,000 of those tests per day.
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