Toronto, Ontario–(Newsfile Corp. – February 26, 2021) – Therma Bright Inc. (TSXV: THRM) (“Therma” or the “Company”), a progressive medical device technology company, is pleased to announce that it has entered into an agreement with a COVID-19 testing site located in the Greater Toronto Area to conduct a clinical study with the Company’s AcuVid TM rapid antigen test for detecting SARS-CoV-2 virus in saliva.
The testing site is located within the Greater Toronto Area that has one of the highest positivity rates in Ontario. The positivity rate around the testing center is currently at 19%. Due to the high positivity rate the Company expects to achieve the minimum number of positive samples required for regulatory approvals more quickly than other locations that were originally considered. Many of the original sites the Company was investigating for clinical trials have been experiencing lower positivity rates due to lockdowns across Canada which would have resulted in a greater expense to the Company along with longer testing periods to complete the clinical testing. The testing site will allow the Company to complete the clinical trial quickly followed by submission of the data to both the FDA and Health Canada.
With a clinical trial agreement signed, Therma Bright can seek Research Ethics Board (REB) approval and Health Canada approval for the proposed trial. Once approval is received, the site will perform the AcuVid TM saliva test on 100 subjects followed by a minimum of 300 subjects. The clinical trial is expected to start during the month of March. Subjects at the COVID-19 testing site will provide nasal samples for the approved lab-based PCR COVID-19 test conducted by Public Health. At the end of the trial, the results of the AcuVidTM saliva test and PCR test will be analyzed and submitted to the FDA and Health Canada as part of the regulatory applications and will also be used to apply for a CE mark in Europe. Therma Bright is in discussions to complete additional clinical trials with the AcuVidTM rapid saliva-based antigen test in the US and other international locations.
Therma Bright is pleased to announce it has rebranded its diagnostic test line as AcuVidTM, which will be used for our existing COVID-19 test and any future related products. The saliva antigen test, the AcuVid TM SARS-CoV-2 antigen test will be the first product as the Company is currently reviewing the addition of other COVID-19 diagnostic tests to create a range of diagnostic products.
Initial results for Therma’s AcuVidTM showed an 86% sensitivity and 100% specificity, which provides Therma Bright with a high level of confidence that the study results will satisfy the regulatory agencies requirements for saliva-based antigen tests. The minimum standard for home-use approval of rapid antigen tests is 80% sensitivity with both Health Canada under the Interim Order and the FDA under Emergency Use Authorization (“EUA”). The results achieved exceed the minimum threshold for approval with regulatory agencies.
Discussions with component suppliers and manufacturing partners have progressed with a view to produce a minimum of 1 million tests per month initially with the ability to scale up as demand increases.
Therma Bright’s goal is to provide a low-cost, scalable saliva-based test for routine and widespread testing of both symptomatic and asymptomatic individuals at home and in schools, workplaces, nursing homes, sporting events, airports and other venues where a rapid result is required. Initially the test will be used in controlled environments such as large companies, sports and music venues, nursing homes, airports, and schools where there is a health care worker or trained staff to assist with performing the test. As the regulations regarding home use become clearer and standardised, the test will be introduced as a home-use test.
Mr. Rob Fia, CEO of Therma Bright, commented:
“We are extremely pleased to have secured our first clinical test site in Ontario. Once we receive REB and Health Canada approval, the testing should be completed in short order at which point we will assemble our regulatory filing package and submit to the FDA and Health Canada. Recently, we have fielded many enquiries for our test from around the world. Our simple, easy-to-use saliva-based test is very attractive for high volume users who want a scalable low-cost solution to keep their companies operating, entertainment venues open and schools and nursing homes safe.”
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.