- Therma Bright Inc. (THRM) has shared another update for its AcuVid COVID-19 Rapid Antigen Saliva Test
- The company has heard from the US FDA that they have completed an initial review of the AcuVid EUA application and have asked for further details and questions to be addressed on the rapid saliva test solution
- The Therma Bright team is working with its strategic partners and suppliers to respond to the FDAs and will resubmit its EUA application with all the additional documentation and tests requested
- Therma Bright Inc. (THRM) is down 17.39 per cent, trading at $0.095 per share as of 10:05 a.m. ET
Therma Bright Inc. (THRM) has shared another update for its AcuVid COVID-19 Rapid Antigen Saliva Test.
Therma Bright stated it has continued to communicate with the U.S. Food and Drug Administration (FDA) regarding a EUA application for its rapid antigen saliva test.
The company has heard from the FDA that they have completed an initial review of the AcuVid EUA application and have asked for further details and questions to be addressed on the rapid saliva test solution.
The Therma Bright team is working closely with its strategic partners and suppliers to respond to the FDA’s questions comprehensively and clearly. Once this is complete, the company will resubmit its EUA application with all the additional documentation and tests requested by FDA reviewers, including details around transport and storage of RT PCR samples and additional data on external controls used.
Rob Fia, CEO of Therma Bright, said his team and strategic partners are all confident in the performance of the AcuVid COVID-19 Rapid Antigen Saliva Test and will provide specific data and details as needed for authorization.
“In tandem, we’ll continue to pursue sales where authorized as we navigate regulatory authorization processes from around the globe.”
The FDA does not provide timelines on how long approvals will take.
Therma Bright is a medical diagnostic, and device technology company focused on providing quality, innovative solutions that address certain medical and healthcare challenges. The company’s initial breakthrough proprietary technology delivers effective, non-invasive, and pain-free skin care.
Therma Bright Inc. (THRM) is down 17.39 per cent, trading at $0.095 per share as of 10:05 a.m. ET.
