COVID-19Regulatory
FDA authorizes first at-home coronavirus test
April 21, 2020 / By James Rogers | Fox News
The FDA has authorized the first diagnostic test with a home collection option for COVID-19, the disease caused by coronavirus.
In a statement released Tuesday, the FDA said that it had reissued an Emergency Use Authorization for LabCorp to COVID-19 RT-PCR Test to permit testing of samples that were self-collected by patients at home using LabCorp’s Pixel by LabCorp 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,” said FDA Commissioner Dr. Stephen Hahn.