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.
    The damage, it seems, had already been done: Following the company's false claims, people scrambled to access the tests. "It crashed the phone line," said Mica when asked how many orders the company had received.
    Mica said that "people desperate to get their hands on these test kits" had been calling her, even though she is a media representative. "It's just been blowing my mind."
    She said she had received messages from people clamoring for tests: "Mothers from North Carolina just wanting to get their kids tested because they've had all of the symptoms. Somebody called me from Tampa."
    A foreign embassy had even called four times, she said.

    A different antibody test has now been authorized

    "HUMANITY GOES HIGH-TECH," Bodysphere says on its website, which also lists N95 masks, sanitizing gel and hospital beds.
    The site, which features photos of lions and an astronaut, says that Bodysphere has "Alchemy Laboratories" and is involved in the creation of "Hemp Bio Plastics."
    The company's most prominent product, though, is its rapid serology test.
    Such tests are able to look for antibodies against the coronavirus -- a sign of recent or past infection even if somebody never showed severe symptoms.
    The FDA has cautioned that serology tests "should not be used as the sole basis to diagnose or exclude [coronavirus] infection or to inform infection status."
    But in an Emergency Use Authorization dated Wednesday, the FDA green-lit an antibody test from a different manufacturer, Cellex Inc.
    The FDA told the company "it is reasonable to believe that your product may be effective in diagnosing COVID-19," adding that the test's benefits outweighed its risks. The Cellex test, then, became the first antibody test authorized by the FDA.
    Beyond diagnosing the virus, serology tests may be useful for research, such as determining what percentage of the population has ever been infected, according to the US Centers for Disease Control and Prevention.
    That would allow researchers to understand how widespread coronavirus infections truly are, including asymptomatic or mild cases. But only the one antibody test, from Cellex, has been explicitly authorized by the FDA as of Thursday.