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Therma Bright Reports Improved Accuracy For Its COVID-19 Rapid Saliva Antigen Test, CoviSafeTM, And Prepares For Prospective Studies
Toronto, Ontario--(Newsfile Corp. - January 18, 2021) - Therma Bright Inc. (TSXV: THRM) ("Ther...
About this update from Therma Bright Inc.
[{"type":"text","content":"Therma Bright Reports Improved Accuracy For Its COVID-19 Rapid Saliva Antigen Test, CoviSafeTM, And Prepares For Prospective StudiesToronto, Ontario--(Newsfile Corp. - January 18, 2021) - Therma Bright Inc. (TSXV: THRM) (\"Therma\" or the \"Company\"), a progressive medical device technology company, is pleased to announce that the most recent results achieved with nanoComposix using banked human saliva samples and utilizing a CoviSafe™ prototype device indicate a test sensitivity of 86% and a specificity of 100% for Therma's CoviSafe™ rapid antigen test for detecting SARS-CoV-2 virus in saliva. As previously reported on December 7, 2020 preliminary results achieved during the feasibility studies indicated a test sensitivity of 80% and a specificity of over 90% for Therma's CoviSafe™. Therma is pleased to have achieved improved sensitivity and specificity with the CoviSafe™ prototype device. This milestone now takes Therma Bright to the prospective clinical study phase which will be followed by regulatory approval applications.Therma's CoviSafe™ prototype test showed an 86% sensitivity for samples with an RT_PCR Ct value below 30 and 100% sensitivity with Ct values of 25 or lower. Ct or Cycle Threshold value indicates the number of times or cycles, that a DNA/RNA sample needs to be amplified for it to be detected by an RT-PCR test - the gold standard test for detecting COVID-19. The lower the Ct value, the higher the amount of viral RNA present in a sample, and the higher the Ct value, the lower the amount of viral RNA present in the sample. Current literature suggests that patients with Ct values below 30 are in the most infectious phase of the disease, so it is critical to identify these people as quickly as possible.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.Therma is in discussions with selected sites in Ontario, the US and international locations to conduct prospective studies with the optimized test. The initial testing of the CoviSafe™ prototype will be for both symptomatic and asymptomatic patients. Therma has been working with Public Health Ontario...