The FDA on Friday authorized emergency use of the first over-the-counter test that can detect both Covid-19 and flu.
The single-use test, made by Lucira Health, is able to differentiate between influenza A and B as well as Covid. It takes about 30 minutes to get results from a self-collected nasal swab.
“Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” top FDA medical device regulator Jeff Shuren said in a statement. The FDA noted that all rapid diagnostic tests have a risk of false positive and false negative results.
“This is a major milestone for Lucira Health and 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 Erik Engelson, president and CEO of Lucira.
Disease burden: The U.S. flu season peaked early last fall and cases are now low, according to the CDC. The agency estimates at least 25 million flu illnesses have occurred this season, resulting in 280,000 hospitalizations and 18,000 deaths.
But there are still a considerable number of Covid-19 infections being recorded each week: more than 236,000 cases and 2,400 deaths were recorded as of the week ended Feb. 22, according to the CDC.
Bankruptcy filing: Earlier this week, Lucira Health filed for Chapter 11 bankruptcy and announced it would try to sell its business.
“The Company anticipated an EUA for an OTC indication on the COVID-19 and Flu test in August 2022, though the FDA’s approval process became protracted, resulting in high expenditures without new revenue from the combined test kit during the 2022-2023 flu season,” Lucira Health said in a press release on Wednesday.
What’s next: Lucira Health said on Friday that it would answer at a later date specific questions about the impact the bankruptcy filing would have on the rollout timing of the test, what current manufacturing capacity is or what the price for the test will be.
“We filed a series of first day motions with the Court and upon approvals, fully intend to move forward in normal course operations, while concurrently pursuing a sale process,” Engelson said in a statement Friday.
The company’s stock price jumped more than 85 percent in after-hours trading.
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