Therma Bright Initiates Clinical Performance Study in Brazil for its AcuVid(TM) COVID-19 Rapid Saliva-Based Antigen Test
Toronto, Ontario--(Newsfile Corp. - March 18, 2021) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), a progressive medical device technology company, is pleased to announce that it has entered into an agreement with Safetest Diagnósticos("Safetest") of Brazil in partnership with the Federal University of Minas Gerais to conduct a clinical performance study of its AcuVidTM COVID-19 Rapid Saliva-based Antigen Test.
Brazil's increase in its COVID-19 infection rate in the past week set another record in terms of new cases and deaths - 12,818 new deaths and more than 464,000 new cases, according to Johns Hopkins University figures. This increase was greater than that seen in the United States, the only country in the world harder hit by the pandemic in absolute numbers.
Because of this, recruitment in this clinical performance study will be completed much faster in Brazil because of the high positivity rate. The study will be conducted under the direction of Dr. Ricardo Fujiwara from the Federal University of Minas Gerais with the support of Safetest. Safetest Diagnósticos was founded in 2016 to bring high quality rapid tests to the market in Brazil and elsewhere. Its first product, the Leishmaniasis Rapid Test, was developed in partnership with the Federal University of Minas Gerais.
Safetest has extensive expertise in the development and validation of antigen and antibody based diagnostic tests with a robust R&D pipeline of diagnostic kits that include tests for Hansen's Disease, Brucellosis, HTLV and blood screening tests. The study aims to validate a minimum of 60 samples of the AcuVidTM COVID-19 Antigen Test with fresh saliva samples of patients. The samples will be confirmed with an approved PCR test.
Rob Fia, CEO, commented, "The tests will be performed on fresh saliva from patients upon admission to the testing facility. Considering the current positivity in Brazil, we are aiming to complete recruitment and complete the study in less than 2 weeks. The study result will supplement and strengthen the evidence of the clinical value of AcuVid saliva test, an accurate and highly specific, easy to use diagnostic tool to help our fight against this pandemic."
Mr. Fia went on to say, "Recent lab results of our locked test showed 100% sensitivity and 100% specificity in most patients when tested within 7 days of onset of symptoms. This is the test that will be entering the performance study."
Dr. Fujiwara commented, "The AcuVID COVID-19 Antigen Test results will be compared to the respective PCR test results which will compare the performance of the tests and will also provide us with real-life data on the ease of use of the device."
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 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.
For further information, please contact:
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, regulatory applications and manufacturing scale up 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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