This is what we’ve been waiting for.
Well, sort of.
The Food and Drug Administration on Tuesday issued an emergency use authorization for the first over-the-counter, fully at-home diagnostic test for COVID-19, a rapid antigen test developed by digital diagnostics company Ellume, which can be used without a prescription.
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Tuesday’s news is a “landmark in the fight against the pandemic,” said Dr. Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University.
“The test isn't the gold standard, but it has enormous potential as a public health tool,” he added, making a point that several other experts echoed on Tuesday. “This will empower individuals to know their COVID status rapidly and to take action to prevent transmission to their family and neighbors.”
Dr. Jennifer Horney, founding director and professor in the University of Delaware’s epidemiology program, noted that it’s “another important tool in fighting COVID-19,” especially considering how many infections are asymptomatic.
For his part, FDA Commissioner Stephen M. Hahn, who in recent days was said to have had his job threatened by the White House for moving too slowly on vaccines, called the antigen test’s authorization a “major milestone in diagnostic testing for COVID-19.”
Of course, it can’t be forgotten that the federal government’s numerous and significant missteps in the realm of diagnostic testing have constituted one of the largest failures in the nationwide effort to control the pandemic. And antigen tests in particular have been blasted for being less accurate than slower PCR diagnostic tests. Critics have also raised questions about how some state and other governments may be using antigen tests to manipulate positive test data.
“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” acknowledged Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, in a release from the agency. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”
Ellume’s test can be sold in places like drug stores, according to Hahn, “where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes.” Anyone over the age of two can use it, and results are delivered via a smartphone app, according to a news release from the FDA on Tuesday.
“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” he added.
Though Horney cautioned that an at-home test can’t and shouldn’t “replace other testing programs or the need for the vaccine,” its authorization is significant when viewed as a step on the path toward a wealth of tests becoming available to the public. Scenes of consumers overloading City MD and other testing locations in recent weeks have become common.
As Boston Children’s Hospital’s Chief Innovation Officer John Brownstein, who is also a researcher at Harvard Medical School, put it, “Rapid at-home testing has always been considered one of the main strategies to combat this pandemic.”
Last month, the FDA authorized an All-In-One Test Kit from California biotech firm Lucira Health. The problem, until now, was that we didn’t have any such tests authorized for at-home use without a prescription, according to Brownstein.
That’s the main factor in Tuesday’s news, “which is needed if we are to use these tools for public health surveillance instead of purely clinical guidance,” he added.
Still, as Horney noted, the company’s plan to produce three million tests in January isn’t large enough to make a serious dent in a nation deluged with cases. “Three million is a small number of tests relatively speaking, so it won’t be a difference-maker right away,” she said.
On that point, Gostin agreed, cautioning that the virus was so widespread today that “we need countless millions of tests” and, unfortunately, “to rely on the goodwill of Americans who will reliably isolate if they have a positive test.”
“With the power of knowledge comes the duty to act responsibly,” Gostin said. “The home test will do no good unless people who test positive self-isolate pending a confirmatory test.”
But, he added, “If millions of Americans use the home test and take preventive action, it could save many lives until we can fully roll out the vaccine.”
