FluroTech LTD. (TSXV: TEST) (OTCQB: FLURF) and wholly owned
subsidiary FluroTest Diagnostic Systems ("FluroTest" or The
Company), a developer of diagnostics technology in high output
rapid antigen testing for the detection of SARS-CoV-2 and other
pathogens, today provided a progress update on its efforts to bring
its Pandemic Response Platform to market.
About FluroTest Diagnostic Systems
Ltd.
FluroTest, a diagnostics technology leader in surge-scale rapid
antigen testing for the detection of SARS-CoV2 and other pathogens,
is developing a pandemic defense and economic recovery system
purpose-built for businesses and special-needs populations
requiring fast and highly accurate testing for a high number of
people. Unlike individual or low-throughput tests, FluroTest's
system is designed to be well-suited for high-traffic, high-risk
pandemic environments including schools and colleges, hospitals and
large healthcare facilities, athletic stadiums and performance
venues, airline and cruise ship terminals, corporate campuses,
shopping centers, manufacturing facilities, transportation and
distribution hubs and other large business and retail locations.
Created to support business continuity efforts and public
well-being, the system combines and leverages the disciplines of
robotics automation, biochemistry, fluorescence detection and cloud
computing – with the concept processing thousands of tests per hour
while delivering accurate, digitally verifiable results to a test
taker's mobile device within 10 minutes.
FluroTest has been developing its “Pandemic and
Emerging Disease Defense Platform” since late January 2021. The
Company has made significant progress in its research and
development efforts during just this 10-month period. Through
continued optimization over the last few weeks, the Company has
achieved what it believes is a breakthrough with it efforts to
optimize its testing protocol and is realizing a 50x to 60x
improvement in all aspects of the process, as compared to the 30x
to 40x it previously reported on November 19, 2021. Based on these
improvements to date, the Company’s test is performing at a level
consistent with approximately 48% of current FDA approved antigen
tests in the market which average at least about 15 minutes per
test and more complicated to administer to a number of people at
once. These improved results have occurred because of the changes
made to its testing protocol. Management believes that, with the
new protocol, it will be able to further improve these results with
additional refinement.
The Company has recruited key advisors, as per
the announcement on June 10, 2021, with deep experience in both
specific technologies being deployed and commercialization of other
diagnostic assays unrelated to COVID. The Company believes that its
technology will represent a disruptive breakthrough in the
development of its high volume, high speed “point of entry/point of
access” testing solution.
Important breakthroughs include:
Fewer steps in sample
processing – The simplified sample processing protocol has
eliminated 43% of the sample processing steps, thus reducing time
and complexity.
Testing protocol simplification
– As a result of the simplification of the testing protocol, the
Company has made great strides in refining the type of
instrumentation required to read processed test samples, further
reducing the time necessary for each reading as well as reducing
the capital cost of field-based instrumentation hardware by as much
as 50% as well as reducing the equipment footprint by 40%. Both of
these improvements make the system accessible to many more “point
of entry” environments, such as airports, schools, university
campuses, hospital entrances, to name a few.
Materials cost per test reduced
– While initial estimates of the direct cost of each test to the
Company would approximate US $5.00 to US $6.00, the Company’s
optimized protocol development efforts are aimed at producing a
direct cost per test of approximately $1.00, thus providing the
Company with flexibility in pricing tests much lower to the
consumer while still maintaining favorable gross profit margins. It
is hoped that this costing will lend itself to mass testing at an
affordable cost and in return should assist in helping to reduce
super spreader events.
Platform solution cost per test
improved – The optimization of sample processing and
equipment necessary to process tests will lower the capital cost
per platform by as much as 50%, thus making the platform solution
more affordable to more potential customers and enabling more
frequent testing.
“The process for scientific discoveries and
innovation takes rigorous work. However, through our scientific
process, the Company has achieved breakthrough improvements this
year. With the adaptation of the Pandemic Defense system to utilize
a new immunoassay technology the development team is gaining
momentum in finalizing assay development for clinical trials. We
will have created a system that can serve a significantly greater
population in even more environments than we originally anticipated
and at a much lower cost, there is still much to do, but we are
optimistic as to the outcome,” said Bill Phelan, CEO of
FluroTest.
The Company expects in 3 to 4 months it will
complete test optimization, protocol development, and prepare to
enter clinical trials.
Readers are cautioned that, although FluroTest
has achieved proof of concept prototype, the testing method and
device is still in the pre-approval stage and accordingly FluroTest
is not currently making any express or implied claims that the
technology can, or will be able to, accurately detect the COVID-19
virus.
About FluroTech (TSXV: TEST) (OTCQB:
FLURF)
The goal of FluroTech's research and technology
is to develop detection methods which are high speed, sensitive,
specific and easy-to-use. By combining FluroTech's proprietary
spectroscopy-based technology with laboratory robotics automation
and cloud computing, FluroTech, through the application of its
technology and investment in FluroTest Diagnostics Systems Ltd.
("FluroTest"), the interests in which have been disclosed in
previous press releases, has created a unique solution addressing
the current and future pandemics. Based upon technology that was
first developed at the University of Calgary, the FluroTest
SARS-CoV-2 test is designed to identify patients with active virus
infection; this is not necessarily the case for most of the
currently approved tests that are meant to identify patients with
SARS-CoV-2 nucleic acid.
To learn more, visit FluroTest.com.
For general FluroTech inquiries:
FluroTech Ltd.
Danny Dalla-Longa, CEO
info@FluroTest.com
Cautionary Statement Regarding
Forward-Looking Information
This news release contains "forward-looking
information" within the meaning of Canadian securities legislation.
Forward-looking information generally refers to information about
an issuer's business, capital, technology or operations that is
prospective in nature, and includes future-oriented financial
information about the issuer's perspective financial performance or
financial position. The forward-looking information in this news
release includes disclosure about the ability of the Company's
testing devices to accurately and quickly detect COVID-19 and to
process large numbers of samples in short time frames, the benefits
of and demand for the Company's testing devices, its efforts to
obtain approval of the FDA and Health Canada, its potential
partnership with a major U.S. based healthcare system and
finalizing plans to conduct clinical trials and its intent to
amalgamate with FluroTest Diagnostics Systems Ltd which owns a 100%
interest in FluroTest LLC. The Company made certain material
assumptions, including but not limited to prevailing market
conditions and general business, economic, competitive, political
and social uncertainties, the ability to obtain FDA and Health
Canada approvals, the demand for its COVID-19 testing devices and
their ability to perform as expected, its potential partnership
with a major U.S. based healthcare system and finalizing plans to
conduct clinical trials and its intent to amalgamate with FluroTest
Diagnostics Systems Ltd which owns a 100% interest in FluroTest LLC
and to obtain the regulatory approvals required in connection with
the same, to develop the forward-looking information in this news
release. There can be no assurance that such statements will prove
to be accurate, as actual results and future events could differ
materially from those anticipated in such statements. Accordingly,
readers should not place undue reliance on forward-looking
statements.
Actual results may vary from the forward-looking
information in this news release due to certain material risk
factors described in the Corporation's Annual Information Form
under the heading "Risk Factors", the failure to develop and
commercialize its testing devices in a timely manner or at all, the
failure to recognize the anticipated benefits from the devices, the
failure to obtain FDA or Health Canada approval for its products,
the risk that regulatory approvals will not be received and the
risk that changing circumstances will result in the decrease in
demand for FluroTest's products. The Company cautions that the
foregoing list of material risk factors and assumptions is not
exhaustive.
The Company assumes no obligation to update or
revise the forward-looking information in this news release unless
it is required to do so under Canadian securities legislation.
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 of this release.
This news release does not constitute an
offer to sell or a solicitation of an offer to buy any of the
securities. The securities described herein have not been and will
not be registered under the United States Securities Act of 1933,
as amended, or the securities laws of any state and may not be
offered or sold within the United States or to or for the benefit
or account of U.S. persons, absent such registration or an
applicable exemption from such registration
requirements.
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