Therma Bright's AcuVid shows specificity, sensitivity THERMA BRIGHT REPORTS PERFORMANCE OF ITS ACUVID COVID-19 RAPID ANTIGEN SALIVA TEST FROM BRAZILIAN CLINICAL STUDY
Therma Bright Inc. has provided an update on the exceptional performance of its AcuVid COVID-19 rapid antigen saliva test's Brazilian clinical study, conducted in Minas Gerais, Brazil.
"The ongoing clinical study for our AcuVid COVID-19 rapid antigen saliva test has performed extremely well," expressed Therma's chief executive officer Rob Fia. "As of June 16, 63 subjects were enrolled and provided a nasal swab for a RT-PCR test and a saliva sample for the AcuVid 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 seven subjects will be received in the coming days. The AcuVid test demonstrated a 100-per-cent specificity for the RT-PCR negative samples. Of the 28 positive RT-PCR results, the AcuVid test had a 100-per-cent sensitivity for RT-PCR results with a Ct value below 27."
Currently, the company is waiting on final results from seven additional test subjects from the 63 total valid individuals in the clinical study, who provided both a nasal swab for an RT-PCR test and a saliva sample. The RT-PCR and Ct results for the remaining seven test subjects will be matched against their AcuVid rapid test. The company anticipates achieving the 30 positive/30 negative requirements for its Food and Drug Administration 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 AcuVid COVID-19 rapid antigen saliva test.
"We're extremely pleased with the performance of the AcuVid test and its 100-per-cent sensitivity for Ct values below 27, as well as the 100-per-cent 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. Over all, the first 56 clinical test results are impressive, and demonstrate the reliability, ease of use and accuracy of Therma Bright's AcuVid 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 AcuVid 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 health care workers responsible for sample collection and testing. Moreover, in a future version of the AcuVid 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 continuing Brazilian AcuVid 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 AcuVid COVID-19 rapid antigen saliva test. Results from the AcuVid test are recorded and later compared with the respective RT-PCR test results postlab work, which takes a day or two and includes the Ct value.
"This is a significant achievement for Therma Bright and our AcuVid COVID-19 rapid antigen saliva test," further expressed Mr. 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.
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 health care needs. The company's initial breakthrough proprietary technology delivers effective, non-invasive and pain-free skin care. Therma Bright received a Class 2 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 U.S. FDA in 1997.
Therma Bright trades on the TSX Venture Exchange: THRM, OTC Markets: THRBF and the Frankfurt Stock Exchange: JNX.