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US begins crackdown on unvetted virus blood tests

Washington DC — U.S. regulators are moving ahead with a crackdown on scores of antibody tests for the coronavirus that have not yet been shown to work.

The Food and Drug Administration on Thursday published a list of more than two dozen test makers that have failed to file applications to remain on the market or already pulled their products.

The agency said in a statement that it expects the tests “will not be marketed or distributed.”

It was unclear if any of the companies would face additional penalties.

Most companies faced a deadline earlier this week to file paperwork demonstrating their tests’ performance.

Regulators required it after previously allowing tests to launch with minimal oversight, which critics said had created a “Wild West” of unregulated testing.

The FDA website shows more than 175 tests have either filed applications with the agency or are in the process of doing so.

A dozen companies have already been reviewed and authorized by the FDA to sell the tests after meeting requirements for accuracy and reliability.

“We have seen a high level of collaboration and engagement from developers who want to get this right,” said FDA Commissioner Stephen Hahn in a statement.

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