Toronto, Ontario–(Newsfile Corp. – December 7, 2020) – Therma Bright Inc. (TSXV: THRM) (“Therma” or the “Company”), a progressive medical device technology company, is pleased to announce the preliminary results achieved during the feasibility studies indicate a test sensitivity of 80% and a specificity of over 90% for Therma’s CoviSafe™ rapid test for detecting SARS-CoV-2 in saliva.
Therma entered into an agreement with nanoComposix, a developer and manufacturer of rapid diagnostic tests to perform feasibility studies with a short list of polypeptides identified by Therma’s strategic partners. Preliminary studies have identified a number of polypeptide pairs that will be tested in the coming weeks in human saliva samples containing the SARS CoV-2 virus.
It is expected that the performance will be improved once the final pair of polypeptide reagents is optimized. The minimum standard for home-use approval of rapid antigen tests is 80% sensitivity with both FDA under Emergency Use Authorization (“EUA”) and Health Canada under the Interim Order. Therma and its partners are pleased to achieve the minimum threshold for approval with regulatory agencies.
In addition to the selection and optimization of the best polypeptide pair of reagents, nanoComposix will assist Therma and its partners in developing a proprietary test cartridge and saliva collection device that will be cost effective, easy to use, secure and suited for routine home-use testing.
Therma will procure up to 300 prototype tests from one of its suppliers to undertake initial testing with selected sites in Ontario. The initial testing of the CoviSafe™ test will be for symptomatic patients. Therma is working with Public Health Ontario to identify sites in the Province to conduct preliminary testing and evaluation of CoviSafe™. Testing is expected to start before year end, but because of potential delays due to the holidays, may extend into January.
As the CoviSafe™ test’s performance is validated in symptomatic patients, it will be rolled out as a screening test for monitoring large populations of healthy individuals that are asymptomatic for illness. Therma Bright has received a request to perform the asymptomatic testing in the workplace with a national business with thousands of employees across Canada. The goal is to provide our solution for routine and widespread testing at home, and in schools, workplaces, sporting events and other venues where a rapid result is required.
Once testing is complete and a minimum set with 300 samples data will be compiled and sent to both FDA and Health Canada for approval under EUA with FDA and the Interim Order with Health Canada. The Company expects to submit data to both regulatory agencies in early 2021. Therma Bright and its partners have initiated discussions with manufacturers of the test with a focus on scaling production on a commercial scale for worldwide distribution.
Mr. Rob Fia, CEO of Therma Bright, commented: ” We are extremely encouraged by the pace of development for our CoviSafe™ test and the interest and support received from potential users, particularly from Public Health Ontario. We are encouraged by the Province’s desire to implement at-home COVID testing for asymptomatic, as well as symptomatic, subjects as soon as possible.”
The Company also announces 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 the Company 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.
Therma Bright is not making any express or implied claims that its product, CoviSafe™, has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.
nanoComposix provides nanoparticles, contract development services and scaled manufacturing to help our customers commercialize nanotechnology products in fields that include biodiagnostics, nanomedicine, and high-performance coatings. For additional information go to, www.nanocomposix.com
About Therma Bright Inc.
Therma Bright is a progressive medical device technology company focused on providing consumers and medical professionals with quality medical devices that address their medical and healthcare needs. The Company’s initial breakthrough proprietary technology delivers effective, non-invasive and pain-free skincare. Therma Bright received a Class II medical device status from the FDA for its platform technology that is indicated for the relief of the pain, itch, and inflammation of a variety of insect bites or stings. The Company received clearance for the above claims from the US FDA in 1997.