The FDA announced today that it granted emergency use authorization (EUA) for an at-home COVID-19 diagnostic test from Laboratory Corporation of America (NYSE:LH).
LabCorp received EUA for its COVID-19 RT-PCR test last month, saying at the time that it would rapidly expand its testing capabilities with the expectation of more than 20,000 tests performed per day by the end of March.
Today, the FDA reissued the EUA for the RT-PC R test to permit testing of self-collected samples for patients at home using the Pixel as part of LabCorp’s COVID-19 test home collection kit.
“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 Dr. Stephen Hahn said in a news release. “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers.
“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. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”
The reissued EUA allows for testing of a sample collected from a patient’s nose through the use of a self-collection kit with nasal swabs and saline. Users self-swab, then mail their sample to LabCorp for testing. The FDA warned that other cotton swabs should not be used with this test, only the specific ones sent in LabCorp’s kit.
LabCorp also intends to make the Pixel home collection kit available to consumers in most states, with a doctor’s order, in the coming weeks, according to the FDA statement.