Therma Bright Inc (TSX-V:THRM, OTC:TBRIF) has announced the submission of its US Food and Drug Administration's Emergency Use Authorization (EUA) application for its smart-enabled AcuVid coronavirus (COVID-19) Rapid Antigen Saliva Test for Point of Care (POC).
"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," said Rob Fia, CEO of Therma Bright, in a statement.
"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. Our team and partners stand ready to deliver upon receipt of FDA EUA."
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Since July 2021, the company said its executive and development teams have worked with FDA officials, doctors, and scientists on its AcuVid EUA application requirements. The company added it will only notify the market upon receipt of the FDA's decision.
"With our AcuVid FDA EUA application submitted, the company has begun investigating another saliva-based testing technology incorporating a robust platform for the detection of other respiratory infectious diseases affecting the lungs, as well as a novel saliva-based platform for Neuro-Vascular disorders (e.g. PTSD, head trauma/concussion)," Fia added.
"We'll keep the market updated on this effort, along with our business progress on our other medical devices."
Therma Bright said it 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.
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