At-home COVID tests by Innova Medical Group: How they work, why they’re still awaiting FDA approval

Written by Danielle Chiriguayo and Amy Ta, produced by Bennett Purser

Today the Food and Drug Administration took a big step toward approving a third COVID-19 vaccine for use in the United States. The agency said its review of the Johnson & Johnson vaccine showed it strongly protects against severe coronavirus cases and completely prevented hospitalizations and deaths in a big clinical trial. The vaccine could be approved this weekend. 

Even with more vaccines, lots of testing will be necessary for a while. The FDA has been moving slowly to greenlight new ways of testing. 

Innova Medical Group, based in Pasadena, has developed a test people can buy over the counter and use at home. It costs $5 and produces results in about 30 minutes. It’s complete with a nasal swab, chemical solution, and paper-like strip. People in the United Kingdom have been using it for months. 

But Innova Medical Group has been waiting for FDA approval since August. 

“What the Innova test would do is something truly at home, like a pregnancy test that you could just go to the drugstore, pick up cheaply, and use continuously to tell yourself what your COVID-19 status is,” says Bryan Walsh, Axios correspondent who covers emerging technology and global trends.

Walsh points out that Innova’s product uses antigen testing, which tests for a high enough viral load that makes a person contagious. He notes similar tests can be about 80% accurate. 

“What it’s looking for is … the viral load in your body, specifically around that kind of contagiousness level,” he says. “This test is very good at detecting [symptoms] and giving you that signal, which then lets you know what you should actually be doing during your day.”

But Walsh says it’s unclear how the FDA authorizes tests, and in this case, they have skepticism around how reliable these home kits are.

“What's really holding it back is the idea on the part of the FDA and others that because they’re somewhat less accurate. Will there be some false positive, some false negatives, or maybe some negative ramifications from that? Will they be misused by people if they're actually being carried out at home, rather than by lab staff at a hospital or a clinic?”

He argues that the nature of the pandemic could force the FDA to think outside of the box and adapt a test that the general public can widely and frequently use. 

Walsh notes that rapid at-home tests might help remind people to consider how they operate in the world and whether they’re infectious, especially as COVID-19 continues to evolve. It might also provide communities with the confidence to re-enter the world and restart the economy. 

“We're going to need to have surveillance around COVID-19 throughout the rest of the year — definitely next winter — if this has a seasonal kind of variation,” he says. “If you have these tests around all the time, you could take one before you go to a restaurant, you'll know that you're safe.” 

He compares the potential of at-home COVID-19 tests to what professional sports leagues have been doing over the last year.

“Look at things like the NBA, the NFL. They do really frequent testing. It's very expensive for them because they use those lab methods, but they've been able to sort of restart the world, restart their businesses. … We could do the same thing too.”