A claim by BodySphere Inc. that its 2-minute Testing Kit To Diagnose Covid-19 received the Emergency Use Authorization or EUA by the U.S. Food and Drug Administration appears to be false.
As per the agency’s April 2 Covid-19 update, 25 companies have received EUA for testing kits to detect the coronavirus from early February till now, but not BodySphere.
The FDA grants Emergency Use Authorizations to make available diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies.
In an earlier press release, BodySphere had claimed that its serology test kit, COVID-19 IgG/IgM Rapid Test Cassette, uses antibodies in blood to test for current or past infection, and results are delivered on site in as fast as two minutes.
The company said then that it was positioned to have millions of its test kits on the front lines in weeks, and is working with State and Federal governments to deliver tests across the country directly to the front lines. BodySphere also claimed that it has already contracted cargo planes to deliver the product to the front lines faster.
Meanwhile, CNN quoted FDA spokesperson Michael Felberbaum as saying, “No serology tests have received an authorization to test for coronavirus.”
Later, BodySphere reportedly said it mistakenly believed to have received the authorization in the rush to deliver tests.
As the COVID-19 continues to sweep across the world, all the countries are racing to develop reliable diagnostic tests as well as a vaccine or treatment against the virus.
Abbott diagnostic test for coronavirus, which delivers fast positive results in as little as five minutes, received the EUA on March 27, while the latest authorizations for testing kits were given to Cellex Inc., Ipsum Diagnostics, LLC, and Becton, Dickinson & Co.
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