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Therma Bright Awaits FDA-EUA Approval From Over 260 AcuVid(TM) Clinical Study Test Results

  • Written by Newsfile

Toronto, Ontario--(Newsfile Corp. - July 22, 2021) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to provide an update on its AcuVid™ COVID-19 Rapid Antigen Saliva Test and awaits an official response from the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) review for its COVID-19 rapid antigen test application.

In addition to exceeding the minimum results for FDA-EUA review with the initial 63 tests from the Brazilian AcuVid™ Saliva / RT-PCR Test Clinical Study, which was publicly announced in June 2021, the Company continued to recruit individuals in the clinical study to secure additional real-life patient data on its AcuVid™ saliva test. In total, 264 individuals were enrolled in the study with duration of symptoms that ranged from one (1) day to more than 10 days.

The Company's overall Brazilian AcuVid™ Saliva / RT-PCR Test Clinical Study, per FDA's EUA data submission requirements; including PPA (Positive Percent Agreement) and NPA (Negative Percent Agreement), delivered better or comparable results, respectively, to those of Abbott's BinaxNOW COVID-19 Ag Card Test's FDA-EUA submission, approved December 2020 (BinaxNOW™ FDA EUA: https://www.fda.gov/media/141570/download[1]).

AcuVid™ COVID-19 Rapid Antigen Saliva Test Results from Brazilian Clinical Study

Percent AgreementPercentage95% Confidence Interval (CI)
PPA (Positive Percent Agreement)85.71%70.15% - 94.22%
NPA (Negative Percent Agreement)97.82% 94.85% - 99.21%
OPA (Overall Percent Agreement)96.21%93.08% - 98.02%

 

Note: Positive percent agreement (PPA) is the proportion of comparative/reference method positive results in which the test method result is positive. Negative percent agreement (NPA) is the proportion of comparative/reference method negative results in which the test method result is negative.

"We're excited to share our overall 264 test results from our Brazilian AcuVid™ Saliva / RT-PCR Test Clinical Study. The additional 201 test results, on top of the initial 63, not only exceed FDA-EUA minimum requirements, but confirms the performance quality and ease-of-use of our AcuVid™ saliva test. In fact, our complete AcuVid™ study achieved comparable, and in some cases, better performance results than other leading COVID-19 rapid antigen tests available on today's market," expressed Rob Fia, CEO of Therma Bright. "Our rapid test solution will allow individuals to safely collect their saliva in a saliva collection device and receive accurate positive or negative COVID-19 results within 15 minutes. Best of all, our test beats the uncomfortable experience of having a swab inserted into your nostrils and swirled around to secure a test result."

Therma Bright's AcuVid™ COVID-19 Rapid Antigen Saliva Test offers quick results, convenience, comfort and cost affordability; all of which are all key features that customers and global communities want to help stop the spread of this mutating virus. Moreover, the AcuVid™ saliva test has successfully been tested against many of the key variants, including the Delta B.1.617.2, P.1, P.2 and B.1.1.7 variant that continue to devastate our global communities. As many nations prepare for Fall 2021 and the Back-to-School season for pre-K through 12 and college students, top scientists and medical doctors around the world continue to evaluate the impact of COVID-19 and the fast-moving Delta B.1.617.2 variant on those who have or have not been vaccinated. Serial testing will continue to play an important and critical role in mitigating the spread and continuation of this unprecedented global pandemic.

"Our nation, along with so many others, have been battling an unseen enemy for over a year with this ongoing global COVID-19 pandemic'" shared former Pennsylvania Governor Tom Ridge, first Secretary for the US Department of Homeland Security. "Therma Bright's clinical study including its easy-to-use, 15-minute and smart-enabled COVID-19 antigen saliva test makes it an ideal solution to help our communities deal with the effects of this virus and help to mitigate its spread and variant mutations."

On March 16, the FDA provided guidance[2] for test developers seeking emergency use authorization (EUA) of certain tests for screening with serial testing. 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.

The Brazilian AcuVid™ Saliva / RT-PCR Test Clinical Study results are being added to the Company's applications for ANVISA (Brazil), INVIMA (Colombia) and Health Canada submissions, and will further support the CE approval received in April 2021.

Therma Bright is pleased to announce that it has applied for a Legal Entity Identifier ("LEI") to maintain its listing on the Frankfurt Stock Exchange. The LEI grants the Company access to European investors, increased liquidity and trading volume and transparency in the global marketplace. The Frankfurt Stock Exchange has regulated that every Issuer of listed securities must have a valid LEI in place to maintain the admission to its markets, thereby following the European Markets in Financial Instruments Regulation. https://www.xetra.com/xetra-en/newsroom/circulars/xetra-circulars/Termination-of-trading-of-securities-of-issuers-without-Legal-Entity-Identifier-LEI--2707646[3]

The Legal Entity Identifier (LEI) is a 20-character, alpha-numeric code based on the ISO 17442 standard developed by the International Organization for Standardization (ISO). It connects to key reference information that enables clear and unique identification of legal entities participating in financial transactions. Each LEI contains information about an entity's ownership structure and thus answers the questions of 'who is who'[4] and 'who owns whom'[5]. Simply put, the publicly available LEI data pool can be regarded as a global directory, which greatly enhances transparency in the global marketplace.

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, developer of the AcuVid™ COVID-19 Rapid Antigen Saliva Test, is a progressive medical diagnostic and device technology company focused on providing consumers and medical professionals with quality, innovative solutions that address some of today's most important medical and healthcare challenges. 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. Therma Bright Inc. trades on the TSXV (TSXV: THRM) (OTC Pink: THRBF) (FSE: JNX). Visit: www.thermabright.com[6].

Therma Bright Inc.Rob Fia, CEO rfia@thermabright.com[7]

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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. 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.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

This press release is not an offer of the securities for sale in the United States. The securities have not been registered under the U.S. Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an exemption from registration. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful.

*SOURCE : FDA Website:Abbott's BinaxNOW™ FDA-EUA submission: https://www.fda.gov/media/141570/download[9]

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/90977[10]

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