Therma Bright Inc. announced that the most recent results achieved with nanoComposix using banked human saliva samples and utilizing a CoviSafeTM prototype device indicate a test sensitivity of 86% and a specificity of 100% for Therma's CoviSafeTM rapid antigen test for detecting SARS-CoV-2 virus in saliva. The company's CoviSafeTM 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. The results achieved exceed the minimum threshold for approval with regulatory agencies. The company 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 CoviSafeTM prototype will be for both symptomatic and asymptomatic patients. The company has been working with Public Health Ontario, US partners, and international partners to identify sites for the prospective testing and evaluation of CoviSafeTM. Testing is expected to start upon approval from one of the study locations. The initial prospective test will test a minimum of 100 CoviSafeTM prototype devices using fresh saliva from the study participants to gain feedback on how the test performs in a real-life setting. This information will be used to improve the CoviSafeTM prototype at which time the final CoviSafeTM design will be locked. The final locked CoviSafeTM design will be used for a minimum of a 300 person prospective study and the data obtained will be used for regulatory approval under the Interim Order with Health Canada and the EUA with FDA and to obtain the CE mark from Europe. The goal is to provide CoviSafeTM 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.