Pasadena-based Innova Medical Group has developed a home COVID test that costs less than $5 per use and delivers results in 15 to 30 minutes. Already approved for use in the U.K. and 19 other countries, the test was submitted to the FDA for final approval in August–and, so far, hasn’t received it.
“I’m a bit frustrated,” Innova CEO Daniel Elliott told USA Today. “I think we’ve done everything we’ve possibly had to do, need to do, and have been asked to do to get the testing through the approval process.”
Mass rapid testing could be a significant factor, along with vaccines and safety protocols, in resuming pre-lockdown life. Quick, home-administered tests may prove particularly important when it comes to bringing children back to schools. There is still no vaccine that has been approved for use in people under 16 years old, and even with testing in younger people currently underway, it could be 2022 before an all-ages vaccine is available.
Right now, Innova is producing many of its kits in China, for sale to the British government and other overseas customers, but it has recently opened a new factory in Brea and plans to open a second local facility in Rancho Santa Margarita. Innova says it has the capacity to assemble 15 million test kits per day, and that capacity could expand to 50 million over the next six months.
“California, actually, in an interesting way, is a net exporter of tests that the United States isn’t using, because of the challenges with the FDA,” Elliott told The Hill. “If the U.S. government today said, ‘OK, go,’ I could deliver 60 million tests before the end of February.”
Independent studies of the Innova test suggest that it has an accuracy of around 79 percent, typically doing well at detecting the virus in symptomatic cases, and less well in asymptomatic patients–a dynamic similar to other antigen tests.
In July, the FDA released guidance that it would be looking for home tests to show a 90 percent accuracy rate to be approved, but the agency later changed that guidance, saying it would in fact consider tests with lower sensitivity.
“We are excited by the potential for at-home tests as a part of our COVID response national strategy and we all want to see them as quickly as possible,” Andy Slavitt, the White House’s senior advisor for coronavirus response, told The Hill. “The best way for us to do that is to get out of the FDA’s way and let them do their jobs.”
Slavitt added that the FDA finds itself in a difficult position of balancing the competing goals of fast authorizations and thorough study.
“We understand that everybody who has something submitted to the FDA wants their product approved,” he said. “I would only observe, having been around the FDA for quite some time, that when they go fast people criticize them, when they go slow people criticize them.”
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