Therma Bright Inc (TSX-V:THRM, OTC:TBRIF) said it has submitted an application to Health Canada for its smart-enabled AcuVid COVID-19 Rapid Antigen Saliva Test for Point-of-Care Use (PoC).
The Toronto-based company said the application includes all the updated data from the company’s US Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) application.
“We’re excited with our AcuVid Health Canada application and the prospect of approval for our unique COVID-19 rapid antigen saliva test for point-of-care (PoC),” said Rob Fia, CEO of Therma Bright, in a statement.
READ: Therma Bright provides update on US FDA application for its AcuVid COVID-19 rapid antigen saliva test
“While we wait for both the US FDA Emergency Use Authorization (EUA) and Health Canada review and approval, our team has begun preparing other regulatory applications, where we believe our AcuVid COVID-19 rapid antigen saliva test will be in high demand this fall when countries from around the globe expect a resurgence of COVID-19,” he added.
Earlier this month, Therma Bright announced that it had submitted follow-up answers and reformatted data to the US FDA for its EUA application after working with officials to clarify answers to some of the application questions.
The company 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.
Therma Bright is a progressive medical diagnostic and device technology company focused on providing consumers and medical professionals with quality, innovative solutions that address some of today’s most important medical and healthcare challenges.
The company’s initial breakthrough proprietary technology delivers effective, non-invasive, and pain-free skincare.
Contact the author at jon.hopkins@proactiveinvestors.com
