Toronto, Ontario–(Newsfile Corp. – September 15, 2020) – Therma Bright Inc. (TSXV: THRM) (“Therma” or the “Company”), a progressive medical device technology company, and its co-development partner, Orpheus Medica Inc. (“Orpheus”) are pleased to provide an update on the development progress of the CoviSafeTM rapid test for detecting SARS-CoV-2 in saliva.
As announced on September 3, 2020, Orpheus identified a series of polypeptides for the screening and detection of the virus (SARS-CoV-2) causing COVID-19. These polypeptides, and others, are being synthesized and when produced will be evaluated in a series of feasibility studies for the selection of the optimal candidates to ensure the best sensitivity and specificity for the SARS-CoV-2 virus. Once the optimal candidates are identified, these polypeptides will be used for testing CoviSafe™ in patient samples.
Orpheus and Therma have also entered into an agreement with a developer and manufacturer of rapid diagnostic tests to perform the feasibility studies with a short list of optimal polypeptides to be provided by Orpheus. The prototype diagnostic or screening test will then be optimized incorporating the polypeptides that exhibit the best performance in terms of sensitivity and specificity as a prototype CoviSafe™ device.
The Company has been in discussions with Health Canada regarding the process for regulatory approval for CoviSafe™. On March 18, 2020, the Government of Canada issued an Interim Order which gives Health Canada the ability to fast track approval of Covid-19 related products. Under this Order, our CoviSafe™ test will be eligible for expedited review and approval by Health Canada.
The initial application of the CoviSafe™ test will be for symptomatic patients and administered by health care professionals. 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. The goal is to provide our solution for routine and widespread testing at schools, workplaces, sporting events or at home.
Mr. Rob Fia, CEO of Therma Bright, commented: “Therma Bright is proud to be an innovative Canadian company. We are impressed with Health Canada for being proactive and taking initiative to assist innovative Canadian companies with the regulatory approval process for Covid-19 solutions such as our rapid saliva test. We look forward to updating investors in the near future as we progress the development of CoviSafe™ with Orpheus Medica.”