Therma Bright Inc (TSXV: THRM) this afternoon halted its equity from trading for the dying minutes of the days session so as to release the latest results from its COVID-19 rapid saliva antigen test while announcing it is preparing for prospective studies. The latest results from testing on the device returned a test sensitivity of 86%, along with a specificity of 100% for the CoviSafe rapid antigen test.
The results released this evening following preliminary results released in early December during a feasibility study. At the time, test sensitivity was reported as being 80%, while specificity was reported at 90%, making the latest figures a slight improvement.
The company also noted that this sensitivity was based on samples with an RT_PCR Ct value below 30, while sensitivity with values of 25 or lower was 100%. Ct is based on the number of times that a DNA or RNA sample needs to be amplified in order for it to be detected. As a result, the lower the Ct value, the higher the amount of viral RNA present in the sample. The minimum standard for home-use approval with Health Canada and the US FDA is 80% sensitivity.
The company is also reportedly in discussions with sites in Ontario, the US and internationally to conduct prospective studies with the test. Initial testing will be for both symptomatic and asymptomatic patients, with testing to begin upon approval from one of the locations. The company is currently looking to test a minimum of 100 prototype devices using saliva from participants to further improve the device. The final version will then be used on a minimum of 300 patients to collect the required data for regulatory approval with Health Canada, the FDA, the EUA, and to receive the CE mark from Europe.
Therma Bright Inc last traded at $0.87 on the TSX Venture.
Information for this briefing was found via Sedar and Therma Bright Inc. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.
