FDA approves first coronavirus test for self-testing at home

FDA approves first coronavirus test for self-testing at home
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The Food and Drug Administration announced in a post Tuesday night that it has issued an emergency use authorization for the first COVID-19 test for self-testing at home — and it returns rapid results.

Why it matters: Coronavirus cases, hospitalizations and deaths from the virus are accelerating across the U.S. This rapid home test could help reduce testing delays.

  • Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement the development is “a significant step toward FDA’s nationwide response to COVID-19.”

Yes, but: This molecular single use test kit developed by Lucira Health is currently available by prescription only.

Of note: Point-of-care settings including doctor’s offices, hospitals, urgent care centers and emergency rooms are also authorized to have this nasal swab testing kit, to be used by people aged 14 or older.

How it works: The Lucira COVID-19 All-In-One Test Kit “works by swirling the self-collected sample swab in a vial that is then placed in the test unit,” the FDA said in a statement.

  • “In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2,” the virus that causes COVID-19, the FDA added.

What they’re saying: FDA Commissioner Stephen Hahn noted in a statement that while COVID-19 diagnostic tests have been authorized for at-home collection, “this is the first that can be fully self-administered and provide results at home.”

  • “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” he said.

For the record: Rapid tests are generally less accurate.

  • The FDA has not addressed the test’s accuracy beyond stating in a letter to Lucira Health on Tuesday outlining that the kit meets its criteria that “it is reasonable to believe that your product may be effective in diagnosing COVID-19.”
  • The FDA, Department of Health and Human Services and Lucira Health did not immediately respond to Axios’ requests for comment on questions including the price of the test kit.

Editor’s note: This article has been updated with new details throughout.