With green lights for routine, at-home screening, FDA sets up over-the-counter tests for COVID-19's endgame

The U.S. government is gearing up for what may become the pandemic’s last phase: While growing numbers of people are walking away vaccinated, COVID-19 testing must still be broadly and easily accessible to help catch and tamp down any future flare-ups.

The FDA issued green lights this week to three manufacturers, allowing them to routinely screen people regardless of whether they’re showing symptoms—including two tests sold over-the-counter in retail stores and used at home for results in less than 15 minutes.

Meanwhile, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) are experimenting with frequent self-testing programs. In two local communities, they're supplying households with monthlong supplies of rapid diagnostics to help stop the spread of the virus.

“Screening testing, especially with the over-the-counter tests authorized today, is an important part of the country’s pandemic response—many schools, workplaces, communities, and other entities are setting up testing programs to quickly screen for COVID-19,” the FDA’s device center director, Jeff Shuren, M.D, said in a statement. “As we’ve said all along, if it’s a good test, we’ll authorize it.”

RELATED: FDA greenlights home COVID-19 testing kits from Quidel, Eurofins

The over-the-counter antigen tests include Quidel’s QuickVue test and multiple versions of Abbott’s BinaxNOW card-based diagnostic, with some that can be performed at home during a telehealth session.

The agency also reauthorized BD’s hand-held Veritor system for routine use by professionals at the point of care without a prescription—the company’s second federal green light this week after a separate Veritor test combining diagnostics for the coronavirus and influenza that BD plans to launch this summer ahead of the next flu season. 

Quidel and Abbott’s tests can be used at home to screen children as young as 2 years old with adult supervision—and are designed to check each person twice in a row over two to three days, with at least 24 hours between tests, for an accurate result.

RELATED: Abbott plans to ship tens of millions of $25, at-home coronavirus tests in early 2021

Abbott said it plans to stock its tests at supermarkets, drug stores and other mass merchandisers, and expects them to be available for purchase on their websites.

"We've now accomplished what we set out to do when we launched BinaxNOW, which is to bring an accurate, affordable and readily available test to the American people that they can have on hand, whether they want to test frequently or in certain circumstances," President and CEO Robert Ford said in a release.

The BinaxNOW test was first made available last August, and production has since scaled up to 50 million kits per month, the company said. The U.S. government, meanwhile, has bought at least 150 million for K-12 schools, nursing homes and historically black colleges and universities. 

A CDC study released earlier this year found the antigen test may miss up to two-thirds of asymptomatic cases, but the BinaxNOW diagnostic was much more successful at detecting people with higher levels of the coronavirus who might be more likely to pass the infection to others.

RELATED: LabCorp to help CDC track COVID-19 mutations as new strain spreads in U.S.

Quidel’s home diagnostic, meanwhile, is similar to a pregnancy test, with a strip and a visual result. 

“Studies are confirming that serial testing with rapid antigen tests is a crucial resource for people to know their current health status and make prudent decisions to protect themselves, their loved ones and their communities,” Quidel President and CEO Douglas Bryant said in a release.

The CDC and NIH plan to provide Quidel’s test to up to 160,000 residents of two counties in North Carolina and Tennessee, free of charge, which they’ll use to screen themselves three times a week for a month. 

“Combined with efforts to increase vaccinations, this important initiative will help us understand how best to utilize these new at-home tests to reduce viral transmission rates in communities,” said CDC Director Rochelle Walensky, M.D., in a statement. 

Dubbed “Say Yes! COVID Test,” the initiative will also give people the option to volunteer for an NIH-supported research study through the University of North Carolina at Chapel Hill and Duke University, which will collect surveys examining whether repeated testing leads to changes in behavior to prevent the spread of the virus and thoughts about vaccination.