Daily Briefing

Around the nation: FDA advises consumers to avoid Cue Health's COVID-19 tests


FDA on Monday warned consumers not to use the at-home COVID-19 tests made by Cue Health, as the tests could give false results, in today's bite-sized hospital and health industry news from Arkansas, California, Georgia, and Tennessee.

  • Arkansas/Tennessee: Republican attorneys general (AGs) from 17 states, led by AGs in Arkansas and Tennessee, filed a lawsuit last month challenging federal rules that entitle workers to time off and other accommodations for abortions. The rules, which were adopted by the Equal Employment Opportunity Commission on a 3-2 vote, were published in April to provide guidance for employers and workers on how to implement the Pregnant Workers Fairness Act (PWFA) and are slated to go into effect on June 18. The lawsuit alleges the rules go beyond the scope of the PWFA. "This is yet another attempt by the Biden administration to force through administrative fiat what it cannot get passed through Congress," said Arkansas Attorney General Tim Griffin. "Under this radical interpretation of the PWFA, business owners will face federal lawsuits if they don't accommodate employees' abortions, even if those abortions are illegal under state law." Dina Bakst, co-president of A Better Balance, said the lawsuit "represents a bad faith effort to politicize what is a vital protection for the health and economic security of millions of families, and a continuation of the alarming attacks on women's health and reproductive choice." (DeMillo, Associated Press, 4/25)
  • California: FDA on Monday warned consumers not to use the at-home COVID-19 tests made by Cue Health, as the tests could give false results. Specifically, FDA said Cue Health had changed the way electrochemical signals within the test were generated, received, and interpreted, and that these changes were not authorized by FDA. As a result, the changes decreased the stability of the tests and could lead to false results. (Trang, STAT+ [subscription required], 5/13)
  • Georgia: CDC on Tuesday launched a public dashboard tracking influenza A viruses in sewage that the agency has been collecting from 600 wastewater treatment sites since last fall in an effort to track the spread of H5N1, also known as bird flu, throughout the country. While the testing isn't specific to H5N1, flu viruses that cause human disease circulate at low levels in the summer. So, a high presence of influenza A in wastewater during that time could indicate something unusual is happening in that area. The dashboard will allow individuals and public health officials to check for any increases in influenza A in their area and compare it to historical data. "We are very much focused on this as an immediate response to the current situation," said Amy Kirby, CDC's wastewater team lead. "And we'll be continuing to work through this as the situation evolves — hopefully resolves. But if … we start getting into the seasonal flu season, we'll have to think about some additional testing to tell those things apart." (Molteni/Branswell, STAT, 5/13)

The future of the at-home testing market: 2 drivers and 2 obstacles

The development of COVID-19 tests and reliance on home-based care have made at-home testing a major market — but is it here to stay? We examine two factors driving its growth and two potential roadblocks to its continued success.


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