Toronto, Ontario--(Newsfile Corp. - January 18, 2021) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), a progressive medical device technology company, is pleased to announce that the most recent results achieved with nanoComposix using banked human saliva samples and utilizing a CoviSafe™ prototype device indicate a test sensitivity of 86% and a specificity of 100% for Therma's CoviSafe™ rapid antigen test for detecting SARS-CoV-2 virus in saliva.
As previously reported on December 7, 2020 preliminary results achieved during the feasibility studies indicated a test sensitivity of 80% and a specificity of over 90% for Therma's CoviSafe™. Therma is pleased to have achieved improved sensitivity and specificity with the CoviSafe™ prototype device. This milestone now takes Therma Bright to the prospective clinical study phase which will be followed by regulatory approval applications.
Therma's CoviSafe™ 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 ("EUA"). The results achieved exceed the minimum threshold for approval with regulatory agencies.
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.
As previously announced on Jan 15, 2021, Mr. Ian Levine has been hired as an advisor to Therma Bright and is currently in the process of sourcing suitable suppliers and manufacturing partners to produce the test once it is approved. 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. We are also exploring the feasibility of setting up new lateral flow assay manufacturing facilities in Ontario with the assistance of our financial partner.
The goal is to provide CoviSafe™ 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.
Mr. Rob Fia, CEO of Therma Bright, commented:
"Therma Bright is working closely with nanoComposix and continues to make great strides to improve the performance of our CoviSafe™ test which we expect to optimize further with our partners. We are in discussions with multiple sites in in Ontario, the US and international locations who are pleased to assist Therma Bright with our prospective studies. We expect to report back to shareholders on our prospective testing in the near future."
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.
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Therma Bright Inc.
Rob Fia, CEO
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FORWARD LOOKING STATEMENTS
Certain statements in this news release constitute "forward-looking" statements. These statements relate to future events such as development and commercialization of a rapid COVID-19 viral assay and related instrumentation, manufacturing PPE and hand sanitizers and applying for government grants to support the Company's future performance. as described in the news release. All such statements involve substantial known and unknown risks, uncertainties and other factors which may cause the actual results to vary from those expressed or implied by such forward-looking statements. Forward-looking statements involve significant risks and uncertainties, they should not be read as guarantees of future performance or results, and they will not necessarily be accurate indications of whether or not such results will be achieved. Actual results could differ materially from those anticipated due to a number of factors and risks. Although the forward-looking statements contained in this news release are based upon what management of the Company believes are reasonable assumptions on the date of this news release, the Company cannot assure investors that actual results will be consistent with these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required under applicable securities regulations.
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