Covid-19: FDA Authorizes First Over-the-Counter Coronavirus Test

Yesterday, the FDA issued the first emergency use authorization for an over-the-counter, fully at-home coronavirus test. FDA Commissioner Dr. Stephen Hahn called the approval “a major milestone in diagnostic testing.”

The self-administered antigen test comes with an electronic analyzer and companion app, which displays results in 15–20 minutes. The test has a sensitivity of 95% and specificity of 97%.

• Sensitivity = The ability to correctly identify patients with Covid-19 with a positive test.
• Specificity = Ability to accurately ID those without Covid-19 with a negative reading.
• False negatives are a risk with rapid tests. But this test holds up well against other rapid ones and could reduce testing pressures on labs and hospitals.

Ellume, the Australian digital diagnostics company behind the test, hopes to scale manufacturing to 100,000/day by January...and deliver 20 million tests to the U.S. in H1 2020. The test will cost ~$30.

Zoom out: The U.S. has issued emergency approval this year for long-range drones, automated resuscitators, and other healthcare innovations. Telehealth and point-of-care testing feel like shifts most likely to stick around.