The 'game changer' that wasn't: Company falsely claimed FDA authorization for coronavirus blood test

Bodysphere claimed it would distribute the first FDA-authorized coronavirus blood test, but a spokesperson later said "there was a misunderstanding."

(CNN)The company claimed it would distribute the first coronavirus antibody test authorized by the US Food and Drug Administration. It promised to detect current and past infections in as little as two minutes -- with just a tiny amount of blood.

"This is a game changer," said the company, Bodysphere, in a statement on Tuesday. It promised to deliver millions of test kits within weeks.
Multiple news outlets reported the announcement. The company's website, with the words "MADE IN USA" beneath a slick logo, showcased photos of the test, including the FDA logo plastered on its box.
    And in a tweet on Monday, Bodysphere said: "It is not the first time we will play a major role in changing the world."
    But the company's claims of an FDA-authorized coronavirus antibody test have been explicitly refuted by the FDA.
    Bodysphere said Tuesday that the serology test had received what is known as an Emergency Use Authorization from the FDA. Serology is another word for the study of blood, and the company claimed the test could detect antibodies with a process as simple as a glucose test.
    But Michael Felberbaum, an FDA spokesperson, told CNN later that day: "No serology tests have received an authorization to test for coronavirus."
    D'Anne Mica, a Bodysphere spokesperson, maintained to CNN throughout the day on Tuesday that the company had received authorization for the test, despite the FDA's statement.
    But on Wednesday, Mica said "there was a misunderstanding" and acknowledged that the FDA never issued the emergency authorization.
    In a statement that night, the company's CEO, Charlton Lui, said his company "mistakenly believed" it had received the authorization "in the rush" to deliver tests, blaming a misunderstanding of paperwork.
    Also on Wednesday, two of the news organizations that reported on Bodysphere -- Reuters and Axios -- retracted their articles.