WASHINGTON — The FDA has issued an Emergency Use Authorization (EUA) for Lucira Health’s rapid coronavirus test, the first one authorized for self-testing at home and priced at an affordable $50. The molecular single-use test, the All-In-One Test Kit, detects SARS-CoV-2 using self-collected nasal swab samples. Under the EUA, it may be used in the
WASHINGTON — The U.S. Food and Drug Administration authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA 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
WASHINGTON — The U.S. Food and Drug Administration issued the first Emergency Use Authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test. “The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out