Therma Bright Inc (TSX-V:THRM, OTC:TBRIF) has said it will submit an application to Health Canada for a review of its AcuVid COVID-19 rapid antigen test for detecting the SARS CoV-2 virus in saliva, adding that it is also looking at other international regulatory jurisdictions.
It follows the company’s application under the Emergency Use Authorization (EUA) guidelines to the US Food & Drug Administration (FDA) for a review of the AcuVid test on March 29, 2022.
The company said the application to Health Canada, which will be made under the Interim Order issued by Health Canada, is substantially equivalent to the one made to the US regulator and uses the test performance data from the US and Brazilian clinical studies and the product manufacturing data provided to the FDA.
"We are pleased to have filed with the FDA in March and shortly with Health Canada,” Rob Fia, CEO of Therma Bright said in a statement. “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.
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“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," the CEO added.
The FDA, under its EUA guidelines, 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 pointed out.
The company said its 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.
"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," Fia said.
The company stressed that 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