Game-changing 2-minute coronavirus test’s FDA approval was false

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A rapid-result coronavirus antibody test that supposedly gained FDA approval had not actually been approved by the FDA at the time of the company’s announcement.
The company, Bodysphere, says the mixup was simple human error, though it insists that its product works as intended and it is now eagerly awaiting a real approval from the FDA.
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The FDA shot down claims from a company that boasted about an FDA-approved blood test that could reveal a coronavirus infection as rapidly as two minutes after a blood draw. The company, BodySphere, stole headlines earlier this week when it claimed its ultra-fast test had passed the FDA’s inspection and been approved. Unfortunately, that wasn’t the case.

The test, which the company boldly called “a game-changer” in the fight against coronavirus, didn’t actually gain FDA approval at all. Speaking with CNN, the FDA noted it had not approved any such test and that it wasn’t sure where the company had gotten its wires crossed.

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Game-changing 2-minute coronavirus test’s FDA approval was false originally appeared on BGR.com on Fri, 3 Apr 2020 at 13:18:46 EDT. Please see our terms for use of feeds.