FDA approves another at-home COVID-19 test

The Food and Drug Administration on Wednesday approved an “at-home, virtually guided” test from Abbott Laboratories that spits out results in 15 minutes and is intended for use by people with suspected cases.

The test reads self-collected nasal swab samples. Users will be guided through the process by a telehealth service that also helps them read and understand their results and report them to public health agencies under local laws.

The test, which costs $25, is the second at-home antigen test to win FDA approval in as many days.

“FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options,” FDA Commissioner Stephen M. Hahn said. “The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.”

Abbott expects to produce 30 million BinaxNOW at-home tests in the first quarter of 2021 and an additional 90 million in the second quarter. It requires a prescription, unlike the over-the-counter test from Ellume approved Tuesday.

The Ellume test is a product of the RadX Tech program at the National Institutes of Health. The program is trying to accelerate the approval of easy-to-use testing systems so the nation can shift from lab-submitted samples, which can take multiple days to return a result, to at-home testing that takes minutes.

Right now, the U.S. is running about 1.7 million to 1.8 million coronavirus tests, mainly through commercial labs. The goal is to get to 6 million tests per day by the end of March.

“We anticipate that shifting, in the January, February and March time frame we would expect the vast majority to be these rapid antigen tests,” Todd Merchak, program director for the RADx Tech, told The Washington Times.

As vaccines roll out, building immunity to the virus, diagnostics will allow the U.S. to keep its eyes on the transmission and find out infectious persons for quarantine.

“It’s absolutely a one-two punch, and testing is going to be needed long-term,” Mr. Merchak said.

Mr. Merchak said the government will continue to work with insurers, states and other payers to make the tests affordable, especially since the antigen tests can produce false positives and need to be followed up with a sensitive “PCR” test or follow-up antigen tests.

A series of at-home tests at $30 a pop would quickly prove cost-prohibitive for people paying out of pocket.

Mr. Merchak said the introduction of new competition will help bring the cost down to $20, $15 or even $5 per test.

He said rapid testing could be useful for employers of frontline workers who can’t stay home during the pandemic, or schools looking to screen teachers. It could also help screen people in professional sports or those who need to check themselves before or after travel.