Wednesday, December 16, 2020

FDA authorizes rapid, at-home Covid test kit, costs –$30 with results in 15 min

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The Food and Drug Administration on Tuesday authorized the first over-the-counter, at-home rapid coronavirus test, which allows users to get their results from an app.

The big picture: A slew of at-home tests are in development, which could make diagnostics easier and faster as the pandemic rages on.

The state of play: Several companies are working on at-home test kits that deliver results digitally, the Wall Street Journal notes.

  • Ellume, the company that received FDA authorization for its at-home test on Tuesday, is working on a function that would let users share their results with their doctor and local health authorities.
  • The FDA asked Lucira Health, which is working on a rapid test, to develop a mobile app or website for better data tracking.
  • Gauss Surgical and Cellex’s test would require users take a photo of their results for an algorithm’s interpretation.
  • On Wednesday, the BinaxNOW COVID-19 Ag Card Home Test was authorized for use by patients at home with a prescription, and will be paired with telehealth options.

Read More

http://allcnaprograms.com/fda-authorizes-rapid-at-home-covid-test-kit-costs-30-with-results-in-15-min/

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