The company's CEO made the following statement about the error on the company's website:
“In the rush to get the desperately needed test kits to the front lines, BODYSPHERE believed when the manufacturer’s product was listed on the FDA Registry website, that was the Food and Drug Administration’s (FDA) notification the Emergency Use Authorization (EUA) was issued. This misunderstanding does not in any way invalidate the test kits authenticity or effectiveness. Under the FDA policy, upon the manufacturer receiving its acknowledgement letter (attached) from the FDA, BODYSPHERE being named the distributor on the EUA submission, was authorized to market and distribute test kits to any licensed healthcare practitioner in the United States for diagnostic use while the manufacturer awaits word of a final decision on its FDA EUA application. The manufacturer has performed clinical trials and the information from those trials will be made available to any healthcare provider or government official seeking to validate the effectiveness and authenticity of these tests.”
If the company does secure the proper authorization from the FDA, we will certainly share the news with you.
Thank you for your understanding.
Sean Fenske, Editor-in-Chief