Regulators at the U.S. Food and Drug Administration on Tuesday authorized the first coronavirus test that lets people collect a sample at home.
"Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options," FDA commissioner Stephen Hahn said in a statement on Tuesday.
The FDA had already cleared LabCorp's test in March under regulations known as an emergency use authorization, geared specifically for situations such as the coronavirus pandemic. On April 5, the company reached out to FDA to ask that it amend that authorization to allow for patients to use it at home. LabCorp's at-home test uses a specific Q-tip-style cotton nose swab, as opposed to previous, longer swabs that required patients to sample themselves deep in the back of the nose.
Confusion over the FDA's rapidly shifting guidelines appeared to lead some companies to initially believe their tests were in the clear. On March 21, federal regulators issued stern guidance which clarified that no home tests had yet been approved for use and warned consumers to be wary of "unauthorized fraudulent test kits." In response to the warning, all three companies stopped selling their kits directly to consumers.
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