The U.S. Food and Drug Administration (FDA) was quick to respond to Bodysphere’s new coronavirus 2-minute rapid detection kit because it has not yet been certified by the agency. Even so, the company insists that its products will yield the expected quick testresults, but are now eagerly awaiting the FDA’s real approval.
Earlier this week, Bodysphere announced that it could quickly detect the presence of new coronavirus antibodies within two minutes of blood withdrawal, and that the “game-changing” new technology “has passed the FDA’s test.”
If Bodysphere’s new serological testing program is effective, it could indeed be an important weapon in the fight against pandemics. Unfortunately, this is not the case.
In an interview with CNN, the FDA said it had not approved any such tests, and it was unclear where the company had come from.
Bodysphere CEO Charlton E. Lui said in a statement that the announcement was made because they wanted to get the much-needed test kits to the front line as soon as possible.
The company’s announcement came when the FDA’s website listed its products on the list published on the website under the Emergency Use Authorization (EUA) rules.
Despite some misunderstandings, however, Bodysphere insists that this will not affect the true effectiveness of its own kit products.
According to FDA policy, manufacturers only have to wait for a final determination after receiving confirmation from the agency. Test kits for diagnostic use may then be sold and distributed to any licensed medical facility in the United States in accordance with the relevant authorization.