A medical worker administers a Covid-19 test at a testing site in Berkeley, California, on Friday, April 17, 2020.
David Paul Morris | Bloomberg via Getty Images
Regulators at the U.S. Food and Drug Administration on Tuesday authorized the first coronavirus test that lets people collect a sample at home.
The authorization of the diagnostic — developed by testing giant LabCorp — marks the first time the agency has cleared an at-home Covid-19 test and caps weeks of back-and-forth between the agency and startups who sought to develop their own versions of the tests that would allow for at-home sample collection. LabCorp’s test will initially be made available to health care workers and first responders who might have been exposed to the virus. Patients can collect samples at home if the test is recommended by a health care provider after they’ve completed a questionnaire about Covid-19.
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“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.
“Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site,” he added.
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. Experts had previously expressed concerns to STAT about the viability of people testing themselves at home using kits that involve longer swabs, which are uncomfortable when done properly.
The agency’s authorization of the LabCorp test for home sample collection comes after a previous flurry of activity between the agency and companies including Nurx, Carbon Health, and Everlywell, all of which had sought to have their own Covid-19 tests approved for at-home use in March.
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.
In April, two other companies began selling Covid-19 tests that let people collect saliva samples at home. The two companies — MicroGen DX and Vault Health — told STAT on April 10 that their tests were cleared for patients to collect spit samples at home. The companies insist they are permitted to sell the tests because they are ordered by physicians and processed in certified labs. The FDA, however, remained adamant that isn’t the case, repeating its previous guidance to STAT on April 10 and emphasizing that the agency “had not authorized any Covid-19 tests for home use, including home collection.” Those tests have still not been approved for home sample collection.