thrmadmin wrote: Therma Bright Awaits FDA-EUA Approval From Over 260 AcuVid™ Clinical Study
Test Results
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).
AcuVid™ COVID-19 Rapid Antigen Saliva Test Results from Brazilian Clinical Study
Percent Agreement Percentage 95% 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 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
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’ and ‘who owns whom’. 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.
Therma Bright Inc.
Rob Fia, CEO
rfia@thermabright.com
Follow us on Twitter:
FORWARD LOOKING STATEMENTS
Certain statements in this news release constitute "forward-looking" statements.