U.S. FDA approves the first coronavirus test with at-home sample collection
FDA’s authorisation of the diagnostic — that was developed by testing giant LabCorp — marks the first time the agency has approved an at-home Covid-19 test. It also caps weeks of back-and-forth between the FDA and startups who sought to develop their own versions of the tests that would enable at-home sample collection.
LabCorp’s at-home COVID-19 test, called Pixel, is an at-home collection kit that provides sample collection materials including a nasal swab to the user, who then uses the included shipping package to return the sample to a lab for testing.
LabCorp’s test will initially be made available to healthcare workers and first responders who might have been exposed to the coronavirus.
Patients can collect samples at home if the test is recommended by a healthcare provider after they have completed a questionnaire about the virus.