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But the company that created the 30-minute over-the-counter check filed for bankruptcy, so the product’s eventual availability to consumers remains uncertain.
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By Christina Jewett and Emily Anthes
On Friday, the Food and Drug Administration issued an emergency authorization for the first combined over-the-counter case of flu and covid in the home, just two days after the company announced it had filed for bankruptcy due, in part, to the long delay in the agency’s approval.
The single-use test works with a self-collected nasal swab and provides a result in about 30 minutes, according to the FDA. a user 2 years of age or older.
The check’s developer, Lucira Health, founded in California’s Bay Area, announced its bankruptcy plan Wednesday, noting that it had waited for its emergency use authorization for the check in August before the flu season avalanche. The company said the agency’s approval procedure “has a lot” and said it has higher expenses as it moves forward with production of the mixing controls.
Without the profits the company expected from planned sales of this year’s flu season tests, Lucira made the decision to continue promoting its business and continue to operate to serve customers, according to its press release. The bankruptcy plan was previously reported in the Wall Street Journal.
On Friday, Dr. Jeff Shuren, director of the FDA’s Division of Devices, called the verification “a major step toward achieving better customer access to diagnostic tests that can be performed entirely at home. “
But even though public fitness experts and scientists welcomed the check’s authorization, it’s still unclear when such a bundle check will be widely sold to consumers. And that uncertainty has compounded considerations others have expressed about the Biden administration’s plans to end the coronavirus public fitness emergency in May, which may complicate access to verification.
People with personal health insurance and Medicare people, who were entitled to 8 loose home tests per month, would have to pay out of pocket for the tests once the emergency is over.
Erik Engelson, Lucira’s lead executive, said Friday that the company was “very excited” by the authorization. “I can’t thank our workers and partners enough for accomplishing this and, of course, for FDA recognition. “he said.
Salud Lucira did not respond to questions about its production capacity or the collection of checks from consumers.
The combined verification identified 99% of the negative samples and 90% of the positive samples for influenza A, according to the FDA. It also detected 100% of negative samples and 88% of positive Covid samples. The firm said it expects the company to continue testing for the influenza B strain, which did not spread this year.
The product is a molecular test, meaning it detects and amplifies the genetic curtains of viruses, like a PCR. test. test performed. These tests are more delicate than antigen tests, and home molecular tests are more expensive than immediate antigen tests.
The new screening will be the first in a series of combined diagnoses at other stages of progression that will look for situations at once, said Dr. Wilbur Lam, a pediatric hematologist and bioengineer at Emory University who has helped federal officials expand controls and validation.
“We are now in this new era that is frankly exciting,” Dr. Lam said. “It’s exciting for a healthcare provider, it’s exciting for generation developers and I think it’s exciting for the public because we have this new test. And that’s just the beginning. “
During the pandemic, some public fitness experts criticized the FDA for being slow to approve at-home covid testing and the federal government for not making testing broader for low-cost or no-cost Americans. It led brands to cut production, which contributed to a shortage of immediate testing when the virus returned.
In the early years of the pandemic, influenza activity was abnormally low. But last fall, when maximum precautions against the pandemic were not taken, influenza reappeared in alarming numbers so early in the flu season. In recent months, Americans have had to contend with waves of various viruses, adding influenza, coronavirus and respiratory syncytial virus, or R. S. V.
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