Therma Bright Inc (TSX-V:THRM, OTC:TBRIF), which is advancing its smart-enabled AcuVid COVID-19 Rapid Antigen Saliva Test, said it will begin its US clinical performance study immediately.
In a statement, the company said the move comes after the Institutional Review Board’s (IRB) conditional approval on November 11, 2021.
Therma Bright said the clinical performance study, per US Food and Drug Administration (FDA) guidance, will begin immediately at three US-based clinics. The results will complement the Brazilian clinical study and other requested test data that have been submitted to the FDA over the past four months, beginning in July 2021.
READ: Therma Bright says ‘on track’ for FDA approval of its COVID-19 rapid antigen saliva test, AcuVid
“We’re pleased to have received IRB conditional approval for our U.S. clinical performance study,” said Rob Fia, CEO of Therma Bright. “Therma Bright can begin moving forward in our efforts with three pre-selected U.S. clinics. Based on current COVID-19 infection rates, we expect the study results to be delivered to the FDA within the next few weeks, as part of our AcuVid application for Emergency Use Authorization (EUA).”
Since mid-July 2021, the company said it has actively engaged with FDA executives, doctors, and scientists on its AcuVid COVID-19 Rapid Antigen Saliva Test application – and anticipates EUA following final FDA review.
Therma Bright 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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Story by ProactiveInvestors
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