- Therma Bright’s (THRM) AcuVid™ COVID-19 Rapid Antigen Saliva Test has exceeded U.S. Food & Drug Administration’s (FDA) Emergency Use Authorization (EUA) requirements
- Therma Bright is the first company to successfully complete a 15-minute rapid antigen saliva-based U.S. study
- The AcuVid saliva test also achieved successful results on several mouth-based bacteria and viruses
- The company has begun work on its FDA EUA efforts for AcuVid At Home Use
- Therma Bright is a progressive medical device technology company
- Therma Bright (THRM) opened trading at C$0.36 per share
Therma Bright’s (THRM) AcuVid™ COVID-19 Rapid Antigen Saliva Test has exceeded U.S. FDA Emergency Use Authorization (EUA) requirements.
The company’s management and product development teams are currently compiling the U.S. Clinical Performance Study results with all supplemental studies into one complete U.S. Food & Drug Administration’s (FDA) EUA application for submission.
Therma Bright is the first company in the COVID-19 diagnostic testing space to successfully complete a 15-minute rapid antigen saliva-based U.S. study.
The AcuVid saliva test also achieved successful results on several mouth-based bacteria and viruses in additional cross-reactivity study requests from the FDA, which other EUA test manufacturers did not have to conduct.
The AcuVid U.S. clinical study was conducted from December 2021 through January 2022. The Brazilian clinical study was completed in July 2021. The Brazilian team detected both the original novel coronavirus Wuhan strain (SARS CoV-2) and the Brazilian P.1 and P.2 and the UK B.1.1.7 variants.
The company has begun work on its FDA EUA efforts for AcuVid At Home Use, and continues to work to improve the performance of its rapid antigen saliva test for this self-test submission.
“We are pleased with the success of our AcuVid™ U.S. Clinical Performance Study, along with our Brazilian clinical study, various cross-reactivity studies and numerous COVID-19 variant studies,” shared Rob Fia, CEO of Therma Bright.
“Since July 2021, our team has worked diligently with FDA officials, doctors and scientists in our pursuit to meet all the EUA requirements. It’s our belief we have achieved all requests and requirements, and have one of the most tested pre-EUA COVID-19 rapid antigen tests for submission. Once our final FDA EUA application for Point-of Care is complete, we will submit and patiently await authorization.”
Therma Bright is a progressive medical diagnostic and device technology company focused on providing consumers and medical professionals with innovative solutions that address some of today’s most important medical and healthcare challenges.
Therma Bright (THRM) opened trading at C$0.36 per share.