This company promised to detect current and past coronavirus infections in as little as two minutes -- with just a tiny amount of blood. But its claims of an FDA-authorized coronavirus antibody test have been explicitly refuted by the FDA.
"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.
In a call Wednesday, after acknowledging that the FDA had not issued an emergency authorization for Bodysphere's test, Mica confirmed that the test is not in any way designed or manufactured in the United States.The company's website still suggests that its products are US-made, however. Beneath the company's logo, for example, are the words"MADE IN USA." And a page on the company's catalog blares"Proudly American" in cursive.
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