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Therma Bright Achieves High Accuracy Results from Feasibility Studies for Its COVID-19 Rapid Saliva Test, CoviSafe(TM)
Toronto, Ontario--(Newsfile Corp. - December 7, 2020) -  Therma Bright Inc. (TSXV: THRM) ...
About this update from Therma Bright Inc.
[{"type":"text","content":"Therma Bright Achieves High Accuracy Results from Feasibility Studies for Its COVID-19 Rapid Saliva Test, CoviSafe(TM)Toronto, Ontario--(Newsfile Corp. - December 7, 2020) -  Therma Bright Inc. (TSXV: THRM) (\"Therma\" or the \"Company\"), a progressive medical device technology company, is pleased to announce the preliminary results achieved during the feasibility studies indicate a test sensitivity of 80% and a specificity of over 90% for Therma's CoviSafe™ rapid test for detecting SARS-CoV-2 in saliva. Therma entered into an agreement with nanoComposix, a developer and manufacturer of rapid diagnostic tests to perform feasibility studies with a short list of polypeptides identified by Therma's strategic partners. Preliminary studies have identified a number of polypeptide pairs that will be tested in the coming weeks in human saliva samples containing the SARS CoV-2 virus. It is expected that the performance will be improved once the final pair of polypeptide reagents is optimized. The minimum standard for home-use approval of rapid antigen tests is 80% sensitivity with both FDA under Emergency Use Authorization (\"EUA\") and Health Canada under the Interim Order. Therma and its partners are pleased to achieve the minimum threshold for approval with regulatory agencies.In addition to the selection and optimization of the best polypeptide pair of reagents, nanoComposix will assist Therma and its partners in developing a proprietary test cartridge and saliva collection device that will be cost effective, easy to use, secure and suited for routine home-use testing.Therma will procure up to 300 prototype tests from one of its suppliers to undertake initial testing with selected sites in Ontario. The initial testing of the CoviSafe™ test will be for symptomatic patients. Therma is working with Public Health Ontario to identify sites in the Province to conduct preliminary testing and evaluation of CoviSafe™. Testing is expected to start before year end, but because of potential delays due to the holidays, may extend into January. As the CoviSafe™ test's performance is validated in symptomatic patients, it will be rolled out as a screening test for monitoring large populations of healthy individuals that are asymptomatic for illness. Therma Bright has received a request to perform the asymptomatic te...