Therma Bright Inc. announced that it will submit an application to Health Canada for review of the company's AcuVid COVID-19 Rapid Antigen Saliva Test for detecting SARS CoV-2 virus in saliva. The application to Health Canada follows an application under the Emergency Use Authorization (EUA) guidelines to the U.S. Food & Drug Administration (FDA) for review of its AcuVidTM COVID-19 Rapid Antigen Saliva Test on March 29, 2022. The application to Health Canada will be made under the Interim Order issued by Health Canada.

The application is substantially equivalent to the one made to FDA and uses the test performance data from the US and Brazilian clinical studies and the product manufacturing data provided to the FDA. The FDA under its Emergency Use Authorization and Health Canada under the Interim Order recommend that candidate tests should demonstrate a minimum sensitivity of greater than 80%. The results achieved by the AcuVid test in clinical studies exceed the minimum threshold for approval by these regulatory agencies.

Therma Bright's goal is to provide a low-cost, scalable saliva-based antigen test for routine and widespread testing of both symptomatic and asymptomatic individuals in schools, workplaces, nursing homes, sporting events, airports and other venues where a rapid result is required. 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.