- Therma Bright (THRM) submits AcuVid™ COVID-19 Rapid Antigen Saliva Test Application for U.S. Food & Drug Administration’s Emergency Use Authorization (EUA)
- Since July 2021, its Executive and Development have worked on application requirements
- Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus
- This test is a progressive medical diagnostic and device technology company focused on providing consumers and medical professionals with quality, innovative solutions
- Therma Bright’s (THRM) is up 9.09 per cent, trading at C$0.24 at 10:29 am ET
Therma Bright (THRM) has submitted its AcuVid™ COVID-19 Rapid Antigen Saliva Test for U.S. FDA Emergency Use Authorization (EUA) approval.
“I am pleased to announce the submission of our AcuVid™ COVID-19 Rapid Antigen Saliva Test for U.S. Food & Drug Administration’s Emergency Use Authorization,” shared Rob Fia, CEO of Therma Bright.
“Our application includes data from our U.S. clinical performance study, Brazilian clinical study, all required cross-reactivity tests, additional FDA requested cross-reactivity tests for mouth-borne viruses and bacteria, and numerous tests around World Health Organization’s (WHO) Variants of Concern (VOCs), such as Delta and Omicron,” added Fia.
Since July 2021, its Executive and Development teams have worked with FDA officials, doctors and scientists on its AcuVid™ EUA application requirements.
The timing of this authorization process is unknown. Therefore, the company will only notify the market upon receipt of the FDA’s decision.
“The company has begun investigating another saliva-based testing technology incorporating a robust platform for detecting other respiratory infectious diseases affecting the lungs and a novel saliva-based platform for Neuro-Vascular disorders,” concluded Fia.
Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.
Therma Bright is the developer of the smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test.
This test is a progressive medical diagnostic, and device technology company focused on providing consumers and medical professionals with quality, innovative solutions that address some of today’s most important medical and healthcare challenges.
Therma Bright’s (THRM) is up 9.09 per cent, trading at C$0.24 at 10:29 am ET.