The Food and Drug Administration (FDA) on Tuesday announced the approval of the first at-home coronavirus test.
“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,” said FDA Commissioner Stephen M. Hahn, M.D. “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.”
The test, called the Pixel, is a nasal swab kit developed and sold by LabCorp. Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing. The test kit costs $119, and potential customers must complete a survey about their eligibility for testing before receiving one.
The FDA said they re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.
The kits will be initially be made available to healthcare workers and first responders who may have been exposed to COVID-19 or may be symptomatic. LabCorp intends to make COVID-19 self-collection kits available to consumers in the coming weeks.