- Therma Bright will conduct a clinical study of the company’s AcuVid TM rapid antigen test
- Test results will be submitted to both the FDA and Health Canada
- The initial trial, slated to begin in March, will involve saliva tests on 100 subjects
- Therma Bright is a progressive medical device technology company
- Therma Bright (THRM) is down 15 per cent, trading at C$0.34 per share at 12:25 pm EST
Therma Bright will conduct a clinical study of the company’s AcuVid TM rapid antigen test.
Therma Bright Inc. (THRM) has entered into an agreement with a COVID-19 testing site located in the GTA to conduct a clinical study with the company’s AcuVid TM rapid antigen test for detecting the SARS-CoV-2 virus in saliva.
The COVID positivity rate around the testing center is currently at 19%. 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) and Health Canada approval for the proposed trial. Once approval is received, the site will perform an initial saliva test on 100 subjects followed by a minimum of 300 subjects.
The clinical trial is expected to start in 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 AcuVid saliva test and PCR test will be analyzed and submitted to the FDA and Health Canada 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 AcuVid 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, leaving Therma Bright confident 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 goal 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 in a range of settings 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 standardized, 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 a progressive medical device technology company focused on providing consumers and medical professionals with quality medical devices that address their medical and healthcare needs.
Therma Bright (THRM) is down 15 per cent, trading at C$0.34 per share at 12:25 pm EST.