FDA Should Get Out of the Way of At-Home COVID-19 Testing

Private-sector efforts to fill the testing vacuum run afoul of bureaucracy.


Four different at-home diagnostic companies are planning to offer tests for coronavirus infection to health care workers and the public in the next week or so. One of the companies is the Austin-based Everlywell, which says it will make as many as 30,000 tests available to health care providers today. The company aims to return results to consumers within 48 hours after the labs receive the test samples, and it says it will offer telehealth consultations to folks who test positive. Positive results will be communicated to all mandated federal and state reporting agencies. The company says it will take no profits from the $135 test.

By working with multiple labs, the company plans to ramp up to a testing and diagnosis capacity for a quarter of a million people weekly. Compare this with the latest Centers for Disease Control and Prevention (CDC) report, which says just under 72,000 tests have been run in the U.S. so far.

Dr. George Rutherford, a physician at the University of California, San Francisco, who investigates the control of infectious diseases, thinks it's important for this to move forward. "Countries like South Korea have done 270,000 coronavirus tests trying to get this thing under control, and America has done far less than that," he told Fortune. "We need a lot of tests in many forms, and we need them now."

The Food and Drug Administration (FDA) has had a different response. "We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19," declared the FDA's associate commissioner for regulatory affairs, Judith A. McMeekin, in a March 20 press release. The agency did acknowledge that it "sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space." Work harder, then.

Diagnostics companies like Everlywell believed that they were authorized to develop their tests under the latest FDA Emergency Use Authorization, which says that any lab that had been certified under the appropriate quality-control standards could start performing coronavirus tests. All four companies are using just such labs to test the samples they collect.

A couple notable cautions for folks who, once the FDA gets out of the way, may want to take advantage of at-home tests:

1. Getting a good sample for testing apparently involves a pretty uncomfortable deep swabbing in the back of your nose and throat. One benchmark is that the swabbing should make your eyes nearly water and make you feel like you're gagging.

2. For some tests, getting results back takes more than week. That is too long.

3. Testing negative is merely a snapshot in time. You are, of course, still at risk of getting infected later.

I am not endorsing these at-home tests. But I should note that I took an Everlywell cholesterol and lipids test a while back and compared its results with results from a test taken at my physician's office. They matched up nicely.