Toronto, Ontario--(Newsfile Corp. - May 10, 2022) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), a progressive medical device technology company, is pleased to announce 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 AcuVid™ 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.
Mr. Rob Fia, CEO of Therma Bright, commented, "We are pleased to have filed with the FDA in March and shortly with Health Canada. We are also exploring other international regulatory jurisdictions where it may be advantageous for us to file and are actively seeking initial orders, subject to final regulatory approvals. Our suppliers and contract manufacturers have been locked down and will provide sufficient capacity to fulfil the initial orders and volume orders as they develop."
"With the detection of new sub-variants of concern such as Omicron BA.4 and BA.5, it has become clear that Covid will be with us for a long time and will probably become endemic much like influenza, necessitating the need for continued vigilance and testing," added Mr. Fia.
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.