- Therma Bright team has been actively engaged with officials at the FDA
- The company has submitted additional research and documentation requested by the FDA
- Therma Bright expects its COVID-19 antigen test to become the first saliva-based rapid test to receive FDA-EUA approval
- Therma Bright is a medical diagnostic and device technology company
- Therma Bright Inc. (THRM) opened trading at C$0.36 per share
Therma Bright (THRM) is pleased to provide an update on the US FDA-Emergency Use application for its AcuVid™ Saliva Test.
Rob Fia, CEO of Therma Bright commented on the status of the application.
“During the past 30 days, the Therma Bright team has been actively engaged with officials at the FDA around our first-of-its-kind AcuVid™ COVID-19 Rapid Antigen Saliva Test and our successful clinical study results.
The team, with support from our US development partners, have successfully completed and submitted additional research and documentation requested by the FDA, and we now await for the Administration to complete its review for Emergency Use Authorization.”
So far testing for Covid-19 has usually involved nose or throat swabs. Therma Bright expects its saliva-based COVID-19 antigen test to become the first saliva-based rapid test to receive FDA-EUA approval.
In addition, the company has also amended its CE application for the AcuVid™ Saliva Test with the new saliva collection and testing process. The AcuVid™ Saliva Test has received CE final approval certification from the EU competent authority of Belgium.
Therma Bright, the developer of the AcuVid™ COVID-19 Rapid Antigen Saliva 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 Inc. (THRM) opened trading at C$0.36 per share.