FDA medical device director Jeff Shuren said the test, which can be fully run outside a lab or health care settings, represents a significant step forward.
“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” Shuren said.
The agency said that the health care providers of patients who use the test must report the results to public health authorities.
Crunching the numbers: The at-home test was able to correctly identify 94 percent of positive samples and 98 percent of negative samples diagnosed using a more sensitive lab-based test in a study, according to Lucira’s instructions for use.
“Excluding samples with very low levels of virus that possibly no longer reflected active infection, Lucira achieved 100% positive percent agreement,” the instructions state.
Background: FDA has previously granted emergency authorization for kits that allow people to take a sample in their home and send it to a lab for testing. But a test people can conduct themselves has been elusive.
Lucira is one of several companies that have been working to develop fully at-home tests to relieve pressure on overburdened testing laboratories and quickly identify new infections.
“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Stephen Hahn said.
Some public health experts, including Harvard University epidemiologist Michael Mina, argue widespread at-home testing could help bring the Covid-19 pandemic in the U.S. under control.
“I believe very firmly that if we asked 100 percent of Americans — maybe we wouldn’t get there — to get tested weekly we could do it,” Mina told POLITICO. To cut down on false positives, a second at-home test that uses a different technological approach should be provided to confirm results, he added.
What’s next: It is unclear how fast Lucira will be able to ramp up manufacturing of the newly authorized at-home test. But FDA says it is eager for more at-home tests to be on the market. Lucira’s website states the test is “intended to cost less than $50” and is manufactured in the U.S.
HHS testing czar Brett Giroir said the health department and Pentagon — which have made investments to boost manufacturing of other Covid-19 tests — are prepared to help Lucira “expand their scope and scale.”
“We look forward to proactively working with test developers to support the availability of more at-home test options,” Shuren said.