ARTICLE | Politics, Policy & Law

FDA is wrong on self-validation of COVID-19 tests

BioCentury is providing this story for free given the urgent need for information about the COVID-19 crisis. For more analysis, sign up for our daily email

April 25, 2020 2:15 AM UTC
Updated on Apr 30, 2020 at 8:04 PM UTC

While the world waits for vaccines and therapies, smart use of public health measures is critical for beating COVID-19. Testing is the essential tool for guiding public health.

FDA, America’s premier public health agency, contributed to the U.S.’s disastrous response by failing early in the outbreak to unleash the nation’s private and academic testing capabilities. It never made sense to wait for CDC to create a test because public health labs aren’t set up to run anything like the number of tests required. CDC’s fumbling of the test made things worse. The country has paid a heavy price for the six to eight weeks lost. ...