The U.S. Food and Drug Administration on Tuesday authorized the nation’s first home COVID-19 test that doesn’t need a lab or medical provider’s prescription.
The test, made by Australia-based Ellume, can deliver results in about 15 minutes and will cost about $30.
Advocates have called for authorization of home tests to alleviate the nation’s testing crunch, which has stressed labs and delayed results for consumers and medical providers. The FDA has previously authorized tests allowing consumers to collect and send samples to a lab. Another home test, Abbott Laboratories BinaxNow, must be administered by a doctor or other provider.
The FDA authorized the Ellume tests for people age 2 and up, with or without symptoms.
Ellume’s rapid antigen test includes a nasal swab for users to collect a sample and place into a cartridge. A smartphone app instructs consumers how to use the test and displays results. It allows results to be shared with a health provider.
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Unlike other at-home tests COVID tests, Ellume’s rapid test can be used by people who have no symptoms.
The Australian company, which signed a $30 million National Institutes of Health contract to develop the test, said it will deliver 20 million home tests to the United States through June 2021.
The company is in advanced talks on “nationwide retail commercialization” and expects to soon share more details with consumers, said Ellume representative Sarah Borton.
U.S. Health and Human Services Secretary Alex Azar said Ellume’s home test is “a major breakthrough for Americans’ ever-expanding access to convenient COVID-19 testing options.”
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In data submitted to the FDA, Ellume’s home test correctly identified 95% of COVID-19 cases and had a 3% false positive rate among patients with symptoms when compared to a lab-based PCR test. The company said its test was even more accurate when used on patients without symptoms.
The FDA warned that a small percentage of antigen tests can produce false negative or false positive results. Patients who test positive and show no symptoms should be presumed positive until another test can confirm results, the FDA said.
Former FDA Commissioner Scott Gottlieb told USA TODAY last week that regulators have a difficult choice in authorizing such home tests. Because these tests are less sensitive than lab tests, some people will test negative even though they really have the virus. If those people get a false sense of security and infect others at home or work, it can help spread the virus. But more widespread testing also could detect more cases and persuade individuals to stay home.
“You’ve got to ask yourself if you are doing more harm than good,” Gottlieb said. “I think in the setting of a pandemic like this where you have a test that is otherwise pretty good, pretty sensitive, pretty specific, as long as you can educate consumers, you are probably going to do more good than harm even with a test that’s going to miss some cases.”
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Dr. Michael Mina, a Harvard epidemiologist who has advocated for rapid home antigen tests, applauded the FDA’s authorization on social media. But he also said the $30 prices is a more expensive than cheaper, paper-based tests he’d like to see authorized.
Illinois-based Abbott said it will charge $5 for its credit card-sized BinaxNow test, but the test is not yet available to the broader medical community. The HHS purchased 150 million BinaxNow tests and set aside 100 million kits for states and 50 million kits mainly for nursing homes, Indian Health Services and historically black colleges and universities.
Mina wants to see more non-prescription tests purchased and distributed by public health agencies, rather than allowing consumers who can afford more expensive tests to buy limited supplies.
“I do hope it doesn’t drive more of a wedge between haves and have-nots,” Mina said on Twitter.
