LabCorp’s at-home COVID-19 test kit is the first to be authorized by the FDA

LabCorp’s at-home COVID-19 test kit is the first to be authorized by the FDA

4 years ago
Anonymous $9CO2RSACsf

https://techcrunch.com/2020/04/21/labcorps-at-home-covid-19-test-kit-is-the-first-to-be-authorized-by-the-fda/

LabCorp’s at-home COVID-19 test, which is called ‘Pixel,’ has received the first Emergency Use Authorization (EUA) for such a test missed by the U.S. Food and Drug Administration (FDA). The test is an at-home collection kit, which 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.

Until now, the FDA has not authorized any at-home testing or sample collection kits for use, and in fact clarified its guidelines to specifically note that their use was not authorized under its guidelines when a number of startup companies debuted similar products for at-home collection and round-trip testing with labs already certified to run molecular RT-PCR tests to detect the presence of COVID-19.