Did the Trump Administration Overpromise 1 Million COVID-19 Diagnostic Tests by the End of This Week?
The FDA has finally approved commercial diagnostic tests.
The United States lags way behind China, South Korea, and even Italy in deploying wide-scale diagnostic testing for the coronavirus responsible for the COVID-19 respiratory illness. For example, China had 5 commercial diagnostic tests available a month ago and can now administer 1.6 million tests per week, according to Science. Private U.S. companies have similarly developed COVID-19 diagnostic tests. In fact, Europe uses, among others, a test developed by the Utah-based biotech company Co-Diagnostics.
In the meantime, U.S. health authorities have insisted on using a diagnostic test devised by the Centers for Disease Control and Prevention (CDC) that turned out to be flawed. In addition, the use of the CDC test limited testing to folks who had traveled to affected countries or who had come into contact with such travelers. This narrow focus was all but guaranteed to miss any community spread of the disease.
On February 29, the Food and Drug Administration (FDA) loosened its regulatory stranglehold on COVID-19 diagnostic testing. On Sunday, Health and Human Services Secretary Alex Azar promised a "radical expansion" of testing by the end of this week. The good news is that on Tuesday, Co-Diagnostics was allowed to begin selling its COVID-19 diagnostic test in the U.S.
At a Senate hearing earlier today, FDA Commissioner Stephen Hahn told lawmakers that he believed that manufacturers should be able to supply by Friday 2,500 test kits enabling laboratories to perform up to 500 tests per kit, amounting to the ability to administer more than 1 million diagnostic tests. Assuming the tests are available, people still have to be tested. On CBS' Face the Nation this past Sunday, former FDA Commission Scott Gottlieb estimated that testing could be ramped up to 10,000 persons per day by the end of the week and up to 20,000 per day by the end of the following week.
Once more widespread testing takes off, we will have a much better handle on just how dangerous COVID-19 is compared to other epidemics of respiratory illnesses such as influenza. Right now, I am betting that it is likely to be no worse than a particularly bad flu season, with a case-fatality rate somewhere between 0.2 and 0.5 percent. That's not great, but it's not apocalyptic.