But the company that created the 30-minute, over-the-counter test has filed for bankruptcy, so the product’s eventual availability to consumers remains unclear.The Food and Drug Administration issued an emergency authorization for the first over-the-counter, at-home combination flu and Covid test on Friday, just two days after the company that makes the test announced that it had filed for bankruptcy protection based, in part, on the agency’s lengthy approval timeline.The single-use test works with a self-collected nasal swab and provides a result in about 30 minutes, according to the F.D.A. The test is meant to be used by people 14 and older, or by an adult collecting a sample from someone age 2 or older.The test’s developer, Lucira Health, based in California’s Bay Area, announced its bankruptcy plan on Wednesday, noting that it had expected its emergency-use authorization for the test in August before the onslaught of the flu season. The company said the agency’s authorization process “became protracted,” and said it had high expenditures as it moved forward with manufacturing the combination tests.Without revenue that the company expected from projected sales of the tests during this year’s flu season, Lucira decided that it would pursue a sale of its business but continue operations to serve customers, according to its news release. The bankruptcy plan was reported earlier in The Wall Street Journal.In a statement issued on Friday, Dr. Jeff Shuren, the director of the F.D.A.’s device division, 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 remained unclear when such a combined test would be widely available for sale to consumers. And that uncertainty compounded concerns that 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 those on Medicare, who have been eligible for eight free at-home tests per month, may have to pay out of pocket for the tests once the emergency ends.Erik Engelson, Lucira’s chief executive, 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 of course, for the F.D.A.’s recognition,” he said.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, according to the F.D.A. It also detected 100 percent of the negative and 88 percent of the positive Covid samples. The agency said it expected the company to continue to test on the flu B strain, which was not prevalent this year.The product is a molecular test, which means it detects and amplifies the genetic material of the viruses, as a P.C.R. test does. These tests are generally more sensitive than antigen tests, and at-home molecular tests have been 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 ailments at once, said Dr. Wilbur Lam, a pediatric hematologist and bioengineer at Emory University who has helped federal officials with test development and validation.“Now we’re in this new era that’s honestly pretty exciting,” Dr. 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.”Through the pandemic, some public health experts have criticized the F.D.A. for being slow to approve at-home Covid tests and the federal government for failing to make the tests more widely available to Americans at little or no cost. Even once at-home tests were approved, fluctuating demand prompted manufacturers to ramp down production, contributing to shortages of rapid tests when the virus came surging back.During the first years of the pandemic, flu activity was unusually low. But last fall, with most pandemic precautions gone, the flu re-emerged in alarming numbers so early in the flu season. Over the last several months, Americans have had to contend with waves of multiple viruses, including influenza, the coronavirus and respiratory syncytial virus, or R.S.V.

The agency may put in place a personalized risk assessment to replace the current prohibition on men who have had sex with men in the previous three months.The Food and Drug Administration is considering a more individualized strategy for screening gay and bisexual men for blood donation amid an ongoing national blood shortage, according to an agency official briefed on the proposal.The F.D.A. has long discouraged men who have sex with men from donating blood. A complete prohibition was put in place in the 1980s, amid fears of H.I.V. transmission. In 2015, the agency allowed gay and bisexual men to donate if they had not had sexual contact with other men for the previous year.The period was reduced to three months after severe blood shortages during the Covid-19 pandemic.The new plan would require potential donors to fill out a questionnaire about recent sexual activity, among other risk factors. Men who have sex with men would be asked a series of follow-up questions. The idea, still under debate, would be to allow those with no new partners in the last three months to donate.The strategy was first reported by The Wall Street Journal. In a statement on Wednesday, the F.D.A. said that new data “will likely support a policy transition to individual risk-based donor screening questions for reducing the risk of H.I.V. transmission.” The broad outlines of the plan are controversial among L.G.B.T.Q. advocates, who say that past blood donation policies were discriminatory and that unequal treatment remains a concern.Read More on the Coronavirus PandemicLong Covid: People who took the antiviral drug Paxlovid within a few days after being infected with the coronavirus were less likely to experience long Covid months later, a study found.Updated Boosters: New findings show that updated boosters by Pfizer and Moderna are better than their predecessors at increasing antibody levels against the most common version of the virus now circulating.Calls for a New Strategy: Covid boosters can help vulnerable Americans dodge serious illness or death, but some experts believe the shots must be improved to prevent new waves.Future Vaccines: Financial and bureaucratic barriers in the United States mean that the next generation of Covid vaccines may well be designed here, but used elsewhere.“I think it is a nominal step in the right direction,” said Sarah Kate Ellis, the president and chief executive of GLAAD, an L.G.B.T.Q. advocacy organization that has been pushing to end the ban for years.“It’s not where it should be, though. Our community and leading medical experts have been saying now for years that these decisions that the F.D.A. is making on blood bans for the L.G.B.T.Q. community are based in stigma and not science. And we’re seeing that pattern continue here.”The new approach is meant to strike a balance between activists who want no restrictions that single out gay and bisexual men and blood banks that want to eliminate the risk of a recipient acquiring H.I.V., according to the F.D.A. official, who requested anonymity to describe the internal discussions.Several large blood centers are wrapping up an F.D.A.-funded study designed to assess the safety of replacing the current three-month waiting period with a more individualized assessment.The researchers, who enrolled about 1,600 gay and bisexual men in eight metropolitan areas, are hoping to identify a set of screening questions that can differentiate men who are more likely to have recently acquired H.I.V. from those who are less likely to have recently contracted the virus.Participants in the project, known as the ADVANCE study, answered a variety of questions about their recent, risk-related behaviors, such as whether they had any new sexual partners or were taking pre-exposure prophylactic drugs, known as PrEP, that reduce the risk of H.I.V. infection, said Brian Custer, director of Vitalant Research Institute and principal investigator of the study.The participants’ blood was also tested for H.I.V. and the antiretroviral drugs used in PrEP.The researchers have already shared an interim analysis with the F.D.A. and should have the final results ready before the end of the year, Dr. Custer said. He declined to provide more information about the preliminary findings, citing a confidentiality agreement with the F.D.A., but said that he expected the results to be informative for the agency.“I really am confident that we have important information for the F.D.A. to be able to consider what an individual, risk-based approach to donor selection might look like,” he said.Susan Stramer, vice president for scientific affairs for the American Red Cross, said in a statement that the study was meant “to make blood donation a more inclusive process while maintaining the safety of the blood supply.”“While we have not been notified by the F.D.A. concerning policy changes at this time, the Red Cross looks forward to a future in which donation eligibility is not based on sexual orientation, and more healthy individuals can give blood to help patients in need,” she said.The current blood shortage is tracked daily by America’s Blood Centers, the trade association for 59 community facilities. On Wednesday, about a quarter of the centers, or 16, had less than a day’s supply on hand.“In this post-pandemic environment, blood drives hosted by businesses — in particular — have not returned to pre-pandemic levels as the way people work has changed,” Nick Gehrig, the senior director for communications at Vitalant, said in an email.