10 COVID-19 testing updates

COVID-19 testing remains a critical barrier to reopening the U.S. economy. 

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Ten testing updates:

  1. HHS overrides states, lets all pharmacists give COVID-19 tests
    New HHS guidance overrides state and local rules that prevented pharmacists from administering COVID-19 diagnostic tests.
  2. FDA approves another at-home COVID-19 test
    The FDA granted emergency use authorization to a second COVID-19 diagnostic test that allows patients to collect samples using nasal swabs.
  3. FDA reviewing accuracy of Abbott coronavirus test
    Abbott’s COVID-19 diagnostic test may return false negatives, the FDA warned.
  4. LabCorp, Quest expand COVID-19 testing
    LabCorp and Quest Diagnostics both said they’ve ramped up their COVID-19 testing capacity.
  5. How feds will divvy up $11B to states for COVID-19 testing
    The White House has revealed how it plans to distribute $11 billion from the CARES ACT to support state testing.
  6. CMS allows pharmacies to bill Medicare for COVID-19 tests
    CMS implemented a temporary policy that allows pharmacies to bill Medicare for COVID-19 tests, a move that could increase the number of pharmacies able to offer diagnostic testing.
  7. FDA gives emergency OK to Abbott’s COVID-19 antibody test
    The FDA granted emergency use authorization for Abbott Laboratories’ new COVID-19 antibody test.
  8. FDA approves first antigen, saliva COVID-19 tests
    The FDA authorized two new types of diagnostic COVID-19 tests this week, the first antigen test and the first at-home test that uses saliva samples.
  9. FDA clears development, sale of at-home COVID-19 tests
    The FDA posted new guidelines that allow manufacturers to develop and market COVID-19 test kits that could be used by people at home and mailed to any lab in the country, a move the agency hopes will significantly increase U.S. testing capacity.
  10. FDA tightens standards for COVID-19 antibody tests
    The FDA strengthened rules for COVID-19 antibody tests after public health officials raised concerns over the quality of the tests, which were allowed on the market without FDA review. 

More articles on supply chain:
AdventHealth cuts ties with lab after 35K COVID-19 test results were found to be unreliable
FDA approves another at-home COVID-19 test
7 recent drug, device recalls

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