A Seattle research project was reportedly told not to conduct coronavirus tests on swabs from flu patients — a missed opportunity early in the US outbreak
Federal officials told a Seattle research lab not to test flu swab samples for coronavirus in January, before the outbreak took hold of Washington state, according to The New York Times. As of Tuesday, Washington has confirmed 267 cases of the virus and 24 deaths. Washington declared a state of emergency on February 29 to tackle the outbreak. Researchers at the Seattle Flu Study told The Times that they had repeatedly asked state and federal officials if they could begin testing their flu samples for coronavirus in January, but were unable to cut through red tape. According to The Times, officials consistently rejected the idea on public health and privacy grounds and said the study did not have explicit permission from its subjects to use their samples for coronavirus testing. The study was not certified for clinical testing. In February, the study began testing its samples without federal permission and confirmed at least one coronavirus case. The report highlights the country's slow response to curbing Washington's coronavirus outbreak. Visit Business Insider's homepage for more stories.
Federal officials reportedly told a Seattle lab researching the flu not to test swab samples for coronavirus before the outbreak took hold of Washington state — a potential missed opportunity early on in the US outbreak. According to The New York Times, a Seattle research group known as the Seattle Flu Study had already been collecting nasal swab samples from residents in the area in January in order to monitor the spread of the flu and other infectious diseases. Around the same time, Washington confirmed its first positive coronavirus case, which prompted Dr. Helen Chu to ask federal and state officials for permission to repurpose the tests in order to monitor the coronavirus spread in the state. But according to The Times, officials consistently rejected the idea on public health and privacy grounds, even as the spread continued throughout the state. Officials also said the study did not have explicit permission from its subjects to use their samples for coronavirus testing, and the study was not certified for clinical testing. In late February, Chu began testing the study's participants for coronavirus without government approval, which confirmed at least one positive case, The Times said. "It must have been here this entire time," Chu told The Times. "It's just everywhere already." As of Tuesday, Washington has confirmed 267 cases of the virus and 24 deaths. King County, where Seattle is located, has recorded over 190 cases of the virus and 22 of the deaths. Washington Gov. Jay Inslee declared a state of emergency on February 29 to tackle the outbreak. The Seattle Flu Study is funded by the Bill & Melinda Gates Foundation, which announced on Monday that it is supporting at-home coronavirus test kits to those at risk in the Seattle area. The foundation also pledged $100 million last month to fight the coronavirus outbreak. The FDA and the CDC did not immediately respond to Business Insider's request for comment. Dr. Robert Redfield, director of the CDC, told The Times that although there were issues with testing in the beginning, there is still time to curb the outbreak in the US. "It's going to take rigorous, aggressive public health — what I like to say, block and tackle, block and tackle, block and tackle, block and tackle," he said. "That means if you find a new case, you isolate it." The FDA told The Times that it provided emergency authorization for two lab-developed coronavirus tests within 24 hours of their completed submission, disputing that it has moved too slowly with testing. On February 29, the Food and Drug Administration (FDA) announced an expansion of its distribution of coronavirus testing kits, allowing hundreds of labs and hospitals around the country to conduct testing that had previously been limited by the CDC. Still, the US lags behind other countries in terms of testing per capita. This chart shows the US testing for coronavirus compared to other countries that have also recorded a large number of coronavirus cases.
As of earlier this week, US has performed about five coronavirus tests per million people, compared with South Korea's 3,692 tests per million people. Test kit shortages and potentially faulty kits initially stalled health authorities' abilities to monitor the number of infections. As of Tuesday, the CDC says that 9,519 tests have been conducted in the US so far: 3698 at its labs and 4856 at US public health labs. The US has reported more than 970 coronavirus cases in total across 37 states.
Read more: One chart shows 11 countries' current coronavirus death rates, based on the known number of cases and deaths Delays and errors have put the US far behind other countries in testing and treating coronavirus patients: 'We are trotting along while they're racing' The US has reported 23 coronavirus deaths among more than 600 cases. Here's what we know about the US patients. CDC: Americans over 60 should stock up on food and medications and avoid venturing out as the coronavirus spreads Join the conversation about this story » NOW WATCH: What's inside a puffer fish
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The FDA ordered an at-home coronavirus testing program funded by Bill Gates to stop testing until the agency gives approval
The US Food and Drug Administration has ordered a Bill Gates-backed coronavirus testing program in Seattle...The US Food and Drug Administration has ordered a Bill Gates-backed coronavirus testing program in Seattle to discontinue indefinitely, The New York Times first reported. SCAN, or the Seattle Coronavirus Assessment Network, was testing 300 people a day before it was ordered by the FDA to stop testing, and applications were to be made public soon. A partnership between five local medical organizations and funded in part by the Gates Foundation, SCAN had only previously received FDA approval surveillance testing, which does not allow researchers to return test results to patients or doctors. Since SCAN researchers returned test results to patients, the FDA specified that its testing protocol would need additional examination before it can receive emergency use authorization (EUA). Visit Business Insider's homepage for more stories. The US Food and Drug Administration has ordered a Bill Gates-backed coronavirus testing program in Seattle to discontinue indefinitely, The New York Times first reported. The testing program, which offered at-home testing kits to Seattle-area residents under authorization from Washington state, was ordered to stop activities and wait for additional approval from the FDA. SCAN, or the Seattle Coronavirus Assessment Network, was testing 300 people a day before it was ordered by the FDA to stop testing, and applications were to be made public soon. In a May 12 blog post, Gates said that SCAN wasn't meant to replace widespread federal testing, but to "paint a clearer picture of how COVID-19 is moving through the community, who is at greatest risk, and whether physical distancing measures are working." But, on May 14, SCAN's website posted an update saying the FDA required additional emergency use authorization (EUA) for self-collected coronavirus tests. The update specified that SCAN asked for EUA on April 13. "There are no issues or concerns with the safety and accuracy of SCAN's test," the update said. Instead, an FDA spokesperson told The Times, the issue seems to be with the categorization and use of SCAN's tests. The tests are categorized as surveillance tests, which can be used by researchers but cannot be given to patients or doctors for diagnostic purposes. Since SCAN was returning results to patients, the FDA said that the program needed to be subjected to guidelines for diagnostic testing. SCAN was launched in early March with funding from the Gates Foundation, and was a collaboration between the Seattle and King County Public Health Department, the Brotman Baty Institute, the medicine faculty University of Washington, the Fred Hutchinson Cancer Research Center, and the Seattle Children's Hospital. According to Gates' blog post, the testing program is an extension of an early flu research program he helped found in 2018, the Seattle Flu Study. The Seattle Flu Study, which previously tracked the spread of the flu during the 2018 season, detected the first coronavirus case in the United States in February. The World Health Organization says widespread testing is necessary for stopping the pandemic. However, numbers show that the US still lags behind other countries in per-capita testing.SEE ALSO: GOP congressman spotted walking around Congress without a mask said "there's just no need" to wear one because of herd immunity Join the conversation about this story » NOW WATCH: Inside London during COVID-19 lockdown
My long-running skepticism about the safety and efficacy of the FDA is fast becoming conventional wisdom....My long-running skepticism about the safety and efficacy of the FDA is fast becoming conventional wisdom. Even normal people can’t believe what they are doing. This piece on the FDA in the New York Times reads like something I might have written for CATO. An innovative coronavirus testing program in the Seattle area — promoted […] The post What is the FDA Doing Now??! appeared first on Marginal REVOLUTION.
The program allows people in the Seattle area to easily take a coronavirus test at home....The program allows people in the Seattle area to easily take a coronavirus test at home. Researchers say such testing is essential for future monitoring of the virus.