FDA Increases Oversight, Requirements for COVID-19 Antibody Tests

After allowing unreviewed antibody tests to pervade the U.S. market for weeks, the FDA is closing its open-door policy for coronavirus blood serology tests—bringing their oversight more in line with the molecular diagnostics used to confirm active cases of COVID-19, according to a FierceBiotech report.

Since mid-March, the FDA has let manufacturers distribute unauthorized antibody tests, provided they validate the tests themselves and do not advertise them as a standalone method of diagnosing a patient. Instead, they could be used to track the spread of the virus through the population, by detecting signs of an immune response to a previous infection.

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