Therma Bright Inc (TSX-V:THRM, OTC:TBRIF) has announced that its US clinical performance study is underway.
Once the clinical data has been completed and tabulated, the final results will be reported to the marketplace and the US Food and Drug Administration (FDA) for emergency use authorization consideration, the company said.
"Our goal is to complete this study in January 2022 within the 300 participants range per our IRB [institutional review board] Clinical Trials dashboard,” Rob Fia, CEO of Therma Bright said in a statement. “With the rapid spread of the Omicron variant, our clinics and their labs have been overwhelmed with a massive wave of COVID-19 RT PCR testing.”
READ: Therma Bright says antibodies in its AcuVid COVID-19 Rapid Antigen Saliva Test can successfully detect Omicron variant
He added: “This has caused delays in receiving these lab-based tests for several days, thus slowing down the process in matching each participant's AcuVid COVID-19 Rapid Antigen Saliva Test with their specific RT PCR test.”
Fia noted that the current results are promising, as the company looks to be the first COVID-19 rapid antigen saliva test to receive FDA Emergency Use Authorization.
Therma Bright, a developer of the smart-enabled AcuVid COVID-19 Rapid Antigen Saliva Test, is a progressive medical diagnostic and device technology company focused on providing consumers and medical professionals with innovative solutions that address important medical and healthcare challenges.
Contact Ritika at ritika@proactiveinvestors.com