First at-home test for flu and COVID cleared by FDA

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The Food and Drug Administration on Friday issued an emergency authorization for the first over-the-counter, at-home combination flu and Covid test, just two days after the company making the test announced it had filed for bankruptcy protection . In part, on the agency’s long approval timeline.

The single-use test works with a self-collected nasal swab and provides results in about 30 minutes, according to the FDA. or older.

The test’s developer, Lucira Health, based in California’s Bay Area, announced its bankruptcy plans on Wednesday, noting that it expected emergency use authorization for the test in August, before flu season strikes. The company said the agency’s authorization process “became lengthy,” and said it had higher expenses as it moved forward with manufacturing the combination tests.

Without the revenue the company expected from projected sales of the tests during this year’s flu season, Lucira decided it would pursue the sale of its business but continue operations to serve customers, according to its news release. The bankruptcy plans were first reported in The Wall Street Journal.

In a statement released Friday, Dr. Jeff Shuren, director of the FDA’s Division of Devices, called the test “a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home.”

But even though public health experts and scientists welcomed the test authorization, it was unclear when such a combined test would be widely available for sale to consumers. And that uncertainty has amplified concerns others have voiced about the Biden administration’s plans to end the coronavirus public health emergency in May, which could complicate access to testing.

People with private insurance and on Medicare, who are eligible for eight free at-home tests per month, may have to pay out of pocket for the tests after the emergency is over.

Eric Engelson, Lucira’s chief executive officer, said in a statement Friday that the company was “very excited” about the authorization. “I can’t thank our employees and partners enough for seeing this through and certainly through the FDA’s accreditation,” he added.

Lucira Health did not immediately respond to questions about its manufacturing capacity or how much the test would cost consumers.

The combination test correctly identified 99 percent of negative and 90 percent of positive Flu A samples, it also detected 100 percent of negative and 88 percent of positive Covid samples, according to the FDA. The agency said it expected the company to continue testing on the Flu B strain, which was not prevalent this year.

The product is a molecular test, meaning that it detects and amplifies the genetic material of the virus in the same way as a PCR test. These tests are generally more sensitive than antigen tests, and at-home molecular tests are more expensive than rapid antigen tests.

The new test will be the first of a series of combination diagnostics in different stages of development that will scan for multiple diseases at once, said Dr. Wilbur Lamm, a pediatric hematologist and bioengineer at Emory University who has helped federal officials with test development and testing. is of. verification.

“We’re in this new era now which is honestly very exciting,” Dr. Lamm said. “It’s exciting for a health care provider, it’s exciting for technology developers, and I think it’s exciting for the public because we have this new test. And it’s just the beginning.”

During the pandemic, some public health experts have criticized the FDA for being slow to approve at-home COVID tests and the federal government for failing to make tests more widely available at little or no cost to Americans. Criticized. Even once at-home testing was approved, fluctuating demand prompted manufacturers to ramp up production, contributing to a shortage of rapid tests when the virus returned.

During the first years of the pandemic, flu activity was unusually low. But last fall, with most epidemiological precautions in place, the flu re-emerged in alarming numbers so early in the flu season. Over the past several months, Americans have had to contend with waves of several viruses, including influenza, the coronavirus, and respiratory syncytial virus, or RSV.

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