Newsfile Corp Toronto, Ontario--(Newsfile Corp. - June 17, 2021) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of the AcuVidT COVID-19 Rapid Antigen Saliva Test and a progressive medical device technology company, is pleased to provide an update on the exceptional performance of its AcuVidT COVID-19 Rapid Antigen Saliva Test's Brazilian Clinical Study, conducted in Minas Gerais, Brazil.
"The ongoing clinical study for our AcuVidT COVID-19 Rapid Antigen Saliva Test has performed extremely well," expressed Therma's CEO Rob Fia. "As of June 16th, 63 subjects were enrolled and provided a nasal swab for a RT-PCR test and a saliva sample for the AcuVidT test. Of the 63, RT-PCR results were received for 56 subjects, with 28 positive and 28 negative results. The RT-PCR results for the other 7 subjects will be received in the coming days. The AcuVidT test demonstrated a 100% specificity for the RT-PCR negative samples. Of the 28 positive RT-PCR results, the AcuVidT test had a 100% sensitivity for RT-PCR results with a Ct values below 27."
Currently, the Company is waiting on final results from 7 additional test subjects from the 63 total valid individuals in the clinical study, and who provided both a nasal swab for a RT-PCR test and a saliva sample. The RT-PCR and Ct results for the remaining 7 test subjects will be matched against their AcuVidT rapid test. The Company anticipates achieving the 30 positive/30 negative requirements for FDA Emergency Use Authorization (EUA) application and will submit when all final results are received, and final documentation is ready. Furthermore, Therma plans to continue the clinical study in Brazil beyond the initial requirements, should any regulatory body require additional test data of the AcuVidT COVID-19 Rapid Antigen Saliva Test.
"We're extremely pleased with the performance of the AcuVidT test and its 100% sensitivity for Ct values below 27, as well as the 100% specificity," shared Dr. Ricardo Fujiwara, the Principal Investigator for the study at the Federal University of Minas Gerais. "Patients with Ct values below 27 are usually in the early phases of this viral infection and are the most contagious. Not only is it important, but also critical, to identify these patients as quickly and accurately as possible to mitigate spread, and this COVID-19 saliva test will do just that! Overall, the first 56 clinical test results are impressive and demonstrate the reliability, ease of use and accuracy of Therma Bright's AcuVidT test. Furthermore, our clinical staff and test subjects found this rapid saliva test far easier to administer and much better tolerated than the standard nasal swab tests."
The AcuVidT COVID-19 Rapid Antigen Saliva Test was specifically designed to allow individuals to 'self-collect' their own saliva in a collection tube. This self-collection process greatly lowers the COVID-19 infection/transmission risk posed to healthcare workers responsible for sample collection and testing. Moreover, in a future version of the AcuVidT test, the saliva collection tube will make it easier for individuals to perform the self-testing in a home environment and better contain their saliva sample and test cartridge in a safe disposable package.
The ongoing Brazilian AcuVidT clinical study is an all-comers design for subjects, both symptomatic and asymptomatic who present at the COVID-19 testing clinic at the University hospital. Each subject first provides a nasal swab for a standard ANVISA-approved high sensitivity RT-PCR test and then provides a saliva sample for use with the AcuVidT COVID-19 Rapid Antigen Saliva Test. Results from the AcuVidT test are recorded and later compared to the respective RT-PCR test results post-lab work, which takes a day or two and includes the Ct value.
"This is a significant achievement for Therma Bright and our AcuVidT COVID-19 Rapid Antigen Saliva Test," further expressed Therma's CEO Rob Fia, "Not only will this clinical data be used for our FDA EUA application submission, but we will also be submitting this clinical data in our Health Canada, ANVISA (Brazil) and INVIMA (Colombia) filings, as well as it will be used to further support our recent CE approval received in April 2021."
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.