The most important part of the NRGoing forward they are aiming at Health Canada, US FDA and European Union approval with the tests that are happening now. Those results and the fact they think they can increase the sensitivity and lock it in with these tests will be enormous.
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, US partners, and international partners to identify sites for the prospective testing and evaluation of CoviSafe™. Testing is expected to start upon approval from one of the study locations. The initial prospective test will test a minimum of 100 CoviSafe™ 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 CoviSafe™ prototype at which time the final CoviSafe™ design will be locked. The final locked CoviSafe™ 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