COVID-19 and the flu have many overlapping symptoms. But FDA on Friday issued an emergency use authorization for the first at-home test that can indicate whether someone has COVID-19, influenza A, or influenza B, marking a "major milestone" for home-based diagnostics.
The newly authorized test is manufactured by Lucira Health — a California-based company that announced its bankruptcy plan last week, citing delays in the test's EUA, which was filed in May 2022 and initially expected in August ahead of the 2022-2023 flu season.
According to FDA, the single-use test uses a self-collected nasal swab and produces a result within 30 minutes, indicating whether a person is positive or negative for COVID-19, influenza A, or influenza B. The test is intended to be used by individuals aged 14 and older, or by an adult collecting a sample for an individual age 2 or older.
Among individuals with symptoms, Lucira's home test accurately detected 88.3% of COVID-19 infections and 90.1% of influenza A infections, according to FDA. In lab studies, the test can also identify influenza B, the agency said. However, because there are not enough cases of the virus circulating in real-world settings, officials noted that further testing will be required.
FDA also warned that, similar to all rapid diagnostic tests, Lucira's test poses a risk of false positive and false negative results. According to FDA, individuals who test positive for COVID-19 or the flu should take appropriate measures and follow-up with their provider.
For individuals who receive a negative result of either COVID-19 or influenza B, the agency recommends confirming results with a molecular test performed in a lab. Individuals who test negative but continue to experience fever, cough, or shortness of breath should also follow up with a healthcare provider to check for other respiratory viruses, according to FDA.
"This is a major milestone for Lucira Health and for at-home diagnostics, and I can't thank our employees and partners enough for seeing this through, and of course, for the FDA's recognition," said Lucira CEO Erik Engelson.
Separately, Jeff Shuren, director of FDA's device division, said the test marks "a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home."
According to Wilbur Lam, a pediatric hematologist and bioengineer at Emory University who has helped federal officials with test development and validation, the new test will be the first of several combination diagnostic tests currently in different stages of development that will be able to screen for multiple conditions at once.
"Now we're in this new era that's honestly pretty exciting," Lam said. "It's exciting for a health care provider, it's exciting for the technology developers, and I think exciting for the public because we have this new test. And this is only the beginning."
While public health experts and scientists praised the test's authorization, many have noted that it is unclear when the combined test will be widely available to consumers.
Throughout the pandemic, FDA received criticism from public health experts for being slow to approve at-home COVID-19 tests and expand testing access. With the end of the COVID-19 public health emergency fast approaching, there have been mounting concerns that access to testing could become strained once again.
In Lucira's bankruptcy hearing, the company's lawyers indicated that it anticipated robust sales of the test kit during Q4 of 2022 and Q1 of 2023, citing reduced COVID-19 precautions, low flu vaccination rates, and conversations with retailers that said they would place "substantial orders" after the test kit gained FDA authorization. However, the "unanticipated" length of the authorization process forced the company to reduce staff two times in the last four months.
Under FDA's EUA program, the combination COVID-19 and flu tests underwent an easier authorization process than flu-only tests undergo. However, Lucira co-founder John Waldeisen, who left the company in 2020, in a tweet accused FDA of "slow-rolling" the submission.
"Should all innovative [medical] device companies have to announce bankruptcy for their products to be cleared?" Waldeisen wrote.
Ultimately, Shuren said FDA "strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs." (Kim, NPR, 2/25; Jewett/Anthes, New York Times, 2/24; Trang, STAT, 2/26)
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