FDA, HHS, NIH Issue Statements On FDA Authorization Of First At-Home, Over-The-Counter Coronavirus Test
FDA: Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19
“… ‘Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,’ said FDA Commissioner Stephen M. Hahn, M.D…” (12/15).
HHS: HHS Secretary Azar Statement on FDA Authorization of First Fully At-Home, Over-the-Counter COVID-19 Test
In a statement, HHS Secretary Alex Azar said the authorization represents “a major breakthrough for Americans’ ever-expanding access to convenient COVID-19 testing options. HHS provided support for this new option through NIH’s RADx initiative, the diagnostics component of Operation Warp Speed, which supports not only development work but also efforts to scale up production to deliver the broadest possible access to new testing options…” (12/15).
NIH: NIH-funded COVID-19 home test is first to receive over-the-counter authorization from FDA
“…Ellume developed the test with a $30 million contract and technical support from the RADx Tech program, managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of NIH…” (12/15).