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Fears of Unregulated 'Wild West' as COVID-19 Blood Tests Hit the U.S. Market

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The FDA decided to waive initial review of the tests as part of its emergency response to the coronavirus outbreak

could play a key role in deciding whether millions of Americans can safely return to work and school. But public health officials warn that the current “Wild West” of unregulated tests is creating confusion that could ultimately slow the path to recovery.

But key questions remain: How accurate are the tests, how much protection is needed and how long will that protection last. Because of the relative simplicity of the technology, the Food and Drug Administration decided to waive initial review of the tests as part of its emergency response to the coronavirus outbreak.

With almost no FDA oversight of the tests, “It really has created a mess that’s going to take a while to clean up,” said Eric Blank of the Association for Public Health Laboratories. “In the meantime, you’ve got a lot of companies marketing a lot of stuff and nobody has any idea of how good it is.”

 

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