Toronto, Ontario–(Newsfile Corp. – May 6, 2021) – Therma Bright Inc. (TSXV: THRM) (“Therma” or the “Company”), developer of the AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce that it has entered into a distribution agreement to white label and distribute a 15-minute rapid COVID-19 antibody test for detecting IgG and IgM antibodies against SARS-CoV-2. The new product will be branded Therma Bright’s AcuVid™ COVID-19 Rapid Antibody Test. This pinprick antibody blood test (i.e. serology test) uses a small amount of blood and has a 96.6% sensitivity for detecting antibodies of SARS-CoV-2 in those individuals currently infected with the virus or who have previously been infected, but went undiagnosed or were unaware of their infection. It will also aid in determining antibodies generated by those who have received a COVID-19 vaccine.
The goal of Therma Bright is to expand its AcuVid™ COVID-19 diagnostic testing product line to help meet the growing demand of the marketplace and to assist in mitigating the spread of the original novel coronavirus virus (Wuhan SARS-CoV-2) as well as the growing list of variants; including Brazilian P.1 and P.2 and the UK B.1.1.7 variants. The antibody test has received CE mark in Europe and ANVISA regulatory clearance in Brazil. Therma Bright will also seek regulatory approvals, as necessary, in other jurisdictions where it plans to sell this product.
The AcuVid™ COVID-19 Rapid Antibody Test is the perfect solution to allow people, who have been exposed to COVID-19 with mild to no symptoms (i.e. asymptomatic) to determine if they have antibodies to SARS-CoV-2. Some countries have been requiring individuals take an antibody test, in addition to an antigen test, before entering their country.
Most importantly, studies have shown the importance of antibody testing, along with serial antigen testing, in controlling and monitoring COVID-19 and vaccine effectiveness. In March 2021, FDA Guidance was provided to test developers who were seeking emergency use authorization (EUA) of certain tests that could be used for serial testing, which includes the AcuVid™ COVID-19 Rapid Antigen Saliva Test. Serial testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test. CDC recommends serial testing at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission. This AcuVid™ Antibody test will be Therma Bright’s second rapid test for serial screening.
“We are pleased to secure this new AcuVid™ COVID-19 Rapid Antibody Test that will complement Therma Bright’s AcuVid™ COVID-19 Rapid Antigen Saliva Test, as more people are infected and while the vaccine roll out continues,” explained Rob Fia, CEO of Therma Bright. “The world is realizing the benefits and challenges with these COVID-19 vaccines, and this antibody test solution will aid in helping our global citizens understand if they have the SARS-CoV-2 antibodies to help them better fight the virus. We’re currently in discussions to supply our new AcuVid™ COVID-19 Rapid Antibody Test to selected customers in Europe and South America.”
In addition, the Company is looking at white-labeling other available government-approved COVID-19 diagnostic test solutions. This goal is three-fold (i) to help address the increased demand for serial testing solutions to mitigate community spread, (ii) to provide funding for production of the CE-approved test while awaiting FDA EUA and Health Canada approval for its premier, smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test, and (iii) to drive revenues for the business and shareholder value.
The Company also announces that it has engaged a consultant to provide services related to web and ecommerce products, including copy and design for the Company’s corporate brand and setting up product page details for the commercial launch of its products, as well as creating marketing and online advertising for its products. Subject to TSXV approval, Therma Bright intends to issue up to 500,000 share purchase warrants to the consultant for the services provided, to be paid in tranches upon certain milestones being met. The warrants will be exercisable for two years and the exercise price will be determined at the time of each issue based on the volume-weighted average closing price of the Company’s common shares on the TSXV for the 5 trading days immediately preceding the date of issue of the warrants.
Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.