FLUROTECH EXPANDS NANOCOMPOSIX MANDATE; INITIATING COVID-19 TEST PERFORMANCE EVALUATION AND VALIDATION
FluroTech Ltd. (TSXV: TEST ) (OTCQB: FLURF ) (“FluroTech” or the “Company”), is pleased to announce that, FluroTest Ltd. (“FluroTest”) has retained San Diego-based nanoComposix, a leading life sciences nanotechnology company that specializes in R&D and manufacturing of lateral flow rapid tests, to immediately begin lab performance studies for FluroTest’s rapid antigen testing pandemic defense platform. This move builds upon previously announced and ongoing optimization efforts, bringing FluroTest one step closer to submitting to the U.S. Food and Drug Administration for Emergency Use Authorization (EUA).
Having already recorded successful proof of concept studies at Albany Medical College’s immunology laboratories, these performance and validation studies will be conducted in accordance with the FDA requirements for antigen testing, including but not limited to; assessments for sensitivity, specificity, limit of detection, cross-reactivity and interfering substances using inactivated viral culture samples. nanoComposix will follow the guidelines for performance studies outlined by the Antigen Template for Test Developers .
“We’re moving methodically but swiftly, and conducting lab evaluations is the next logical milestone to tackle as we march toward commercialization,” said FluroTest CEO, Bill Phelan. “We believe that these performance studies will reaffirm our efforts to introduce this novel solution to a massive, underserved market. My goal is to not only make FluroTest an icon of scientific culture, but rather an icon of our culture at large.”
nanoComposix has worked with over 100 different clients to develop materials, composites and formulations with tailored optical and physical properties for a wide range of applications including medical devices, nanoparticle drug delivery, optical sensors, and consumer products. A multidisciplinary team of scientists with backgrounds in chemistry, physics, and engineering have been tapped to run the evaluations, utilizing nanoComposix’s in-house BSL-2 laboratory for handling inactivated viral cultures.
“FluroTest has developed a Covid-19 diagnostic platform that we anticipate will be able to screen thousands of people per platform each hour – an unprecedented throughput that will be necessary to re-open the economy,” said Steve Oldenburg, CEO of nanoComposix. “We believe that the powerful combination of nanoComposix’ ultra-sensitive detection technology with state of the art robotics automation will be a revolutionary advance in Covid-19 diagnostic testing.”
“We believe that our FluroTest platform is unique in its sensitivity and throughput to rapidly detect the presence of SARS CoV-2 in saliva samples – we’re excited to expand our working relationship with the nanoComposix team to bring this game changing technology to market,” added FluroTech R&D Director and Senior Scientist, Dr. Mauricio Arias.
Readers are cautioned that, although FluroTest has achieved proof of concept prototype, the testing method and device is still in the early stages of research and development 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. The Platform is currently pending FDA approval.
FluroTech ’s proprietary spectroscopy-based technology allows for the testing and identification of organic and inorganic compounds contained within biological samples for specific applications. Using technology that was first developed at the University of Calgary, FluroTech has created a two-part solution comprising its CompleTest ™ platform technology and consumable testing kits. Its accuracy has been independently validated. FluroTech continues to develop additional applications for the CompleTest TM platform technology. To learn more, visit FluroTech.com
About FluroTest LLC
FluroTest, a first-mover 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 efficient testing for significant numbers 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 executive business continuity efforts, the system combines and leverages the disciplines of robotics automation, biochemistry, fluorescence detection and cloud computing — processing thousands of tests per hour while delivering accurate, digitally verifiable results to a test taker’s mobile device within 5 minutes. To learn more, visit FluroTest.com
nanoComposix ( www.nanocomposix.com ) has been providing customers with precisely engineered and highly characterized nanoparticles for more than 15 years, offering hundreds of different variants of material, size, shape, and surface functionalization as stock products. Their multidisciplinary technical teams provide rapid prototyping, characterization, integration, and scale-up solutions to accelerate R&D and commercialization for a wide variety of applications. nanoComposix is committed to helping its customers bring nanotechnology-enabled products to market and executes contract manufacturing on scales ranging from small beakers to thousands of liters. Nanomaterials for medical devices and clinical trials are fabricated in ISO13485 and cGMP compliant cleanroom facilities.
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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 prospective 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, and the ability of nanoComposix to assist the Company in developing and commercializing its products. 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, 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.
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