FDA Pulls Chembio’s Rapid Test As Purge Of ‘Inaccurate’ Antibody Tests Continues
Chembio’s stock opened down 60% the day after the FDA’s decision to revoke its EUA for the first US rapid test for antibodies to SARS-CoV-2.
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Autobio’s test reportedly only correctly identified half the positive SARS-CoV-2 antibody samples in an NIH evaluation.
While the main role of SARS-CoV-2 antibody testing is currently limited to determining exposure to the virus in populations, the scientific community is working hard to define the neutralizing properties of the antibodies detected, and the duration of the immune response. As a result, antibody testing could be here to stay for the long term for monitoring populations, testing vaccines and selecting patients for trials of a variety of new therapies to treat numerous conditions.
After criticism it was being too lax in overseeing COVID-19 antibody tests coming to market, the US agency issued an updated guidance earlier this month tightening regulations. As a result, it has now pulled more than two dozen tests that don’t meet its standards – and more are expected to follow.