FDA warns new at-home coronavirus tests are unauthorized
In response to the nationwide dearth of Covid-19 tests, private companies have stepped up — offering direct-to-consumer tests for the novel coronavirus. At least four startups will begin selling these at-home tests this week.
Now, though, the FDA has released a statement meant to alert consumers, saying the agency hasn't authorized any at-home tests. Regulators worry that the DTC tests might not meet the FDA’s high standards for approval — and consumers may wind up with an inaccurate result if they don’t swab deep enough in their nose or throat.
The companies, however, say their tests are sanctioned under loosened rules meant to expand Covid-19 testing, and are fair game.
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