Bodysphere clarified that it did not receive an emergency use authorization (EUA) from the FDA for its COVID-19 diagnostic test as previously announced.
The company said that it is still waiting for a final decision from the FDA and only received an acknowledgement letter from the agency that the EUA submission was received.
“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 the authorization was issued, according to Bodysphere’s CEO Charlton Lui.
The confusion about the EUA approval does not invalidate the test kit’s effectiveness, Lui said.
The blood test identifies both current and past infection and can deliver results in two minutes.