FDA approves more than 100 COVID-19 tests; hundreds more in development

WASHINGTON, D.C. — Hundreds of companies are racing to make tests that detect whether someone has or has had COVID-19.

The U.S. Food and Drug Administration (FDA) said it’s been working with more than 400 test developers, and so far 104 tests have been authorized.

That includes the approval of 12 COVID-19 serology tests, commonly known as antibody tests.

“Coronavirus

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Those are meant to show whether someone has previously been infected with the virus and has since recovered.

Scientists say antibody tests could show whether a person is immune, though the World Health Organization cautions that immunity is not a guarantee yet and that studies are still underway.

The FDA also approved 91 molecular tests, which involve swabbing the back of the nasal passage to determine whether someone currently has the virus.

Earlier this month, the FDA also approved the first COVID-19 antigen test.

It’s a new kind of test that is meant to get faster results.

Manufacturers and laboratories took part in a virtual town hall with the FDA Wednesday and discussed the approval process for testing and the effectiveness of different methods.