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FDA Orders Companies Selling Coronavirus Antibody Tests To Submit Data Proving Accuracy Within 10 Days

  • May 05, 2020

The New York Times (5/4, Kaplan) reports the FDA “announced on Monday that companies selling coronavirus antibody tests must submit data proving accuracy within the next 10 days or face removal from the market.” While the tests aim to determine whether a person has been previously infected by the coronavirus, there has been widespread variation in results, and “since mid-March, the agency has permitted dozens of manufacturers to sell the tests without providing evidence that they are accurate.”
      The AP (5/4, Perrone) reports the agency “said it took the action because some sellers have made false claims about the tests and their accuracy.”
      Other sources covering the story include: CNN (5/4, Murray), The Hill (5/4, Weixel), Reuters (5/4, Humer), the Wall Street Journal (5/4, Burton, Subscription Publication), Politico (5/4, Lim), and HealthDay (5/4, Thompson).