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Therma Bright Enters into Clinical Trial Agreement for its AcuVid(TM) COVID-19 Rapid Saliva-Based Antigen Test
Toronto, Ontario--(Newsfile Corp. - February 26, 2021) - Therma Bright Inc. (TSXV: THRM) ("The...
About this update from Therma Bright Inc.
[{"type":"text","content":"Therma Bright Enters into Clinical Trial Agreement for its AcuVid(TM) COVID-19 Rapid Saliva-Based Antigen TestToronto, 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 tes...