This week Therma Bright (TSXV: THRM) announced the sensational test results of a highly accurate feasibility study showing that the potential saliva test CoviSafe™ has a test sensitivity of 80% and a specificity of more than 90%. The test is intended to quickly and efficiently detect Covid-19 in patients and meets the minimum standard of the FDA and Health Canada.
These are still preliminary results, but the big step towards a well-functioning and soon operative product seems imminent. An agreement with nanoComposix allowed the rapid diagnostic tests required for the feasibility study to be performed. The study consists of a short list of polypeptides identified with the Covid-19 virus. Preliminary studies have identified a number of polypeptide pairs that will be thoroughly tested in the coming weeks in human saliva samples containing Covid-19 virus.
Why the preliminary test results are more than welcome has to do with the minimum standard for approval of rapid antigen testing for home use. It has been set at 80% sensitivity by the FDA under Emergency Use Authorization and Health Canada under the Interim Order. With this Therma Bright has reached the minimum standard and can prepare itself for the near sale of CoviSafe™. Especially since it is expected that the performance will improve once the last pair of polypeptide reagents are optimized.
In addition, nanoComposix has announced that it will further assist Therma in developing a patented test cartridge and saliva collection device. This is seen as a very suitable test for routine home use that is above all labeled as cost-effective, user-friendly and very safe. The interest is overwhelming, as society are letting the company know that it recognizes the need for such test and on a daily basis. It has a stimulating effect and shows the demand for Covid-19 tests for home use.
Therma plans to purchase up to 300 prototype tests from a supplier before 2021, in order to run the first tests at selected locations in Ontario. In partnership with Public Health Ontario, Therma will identify the most appropriate locations to conduct the tests with CoviSafe™. It is important that the tests are performed as soon as possible (at most January, 2021) so the residual results can be sent to the FDA and Health Canada rapidly. The company is now looking at scaling-up options so that, upon approval, it can immediately leverage commercial-scale production for global distribution.
Now that the performance of CoviSafe™ has been validated in symptomatic patients, it will be rolled out as a screening test to monitor large populations of healthy individuals asymptomatic for disease. As a result of recent developments, a major Canadian company has approached Therma to conduct asymptomatic workplace testing. It will involve thousands of employees across the country.
Last but not least, Therma announced that pursuant to the Company’s 10% rolling stock option plan and in compliance with the policies of the TSX Venture Exchange, it has granted incentive stock options to consultants of Therma to purchase up to an aggregate of 550,000 common shares of the company. These options are exercisable for a period of 5 years at a price of $0.22 per share.
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