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CALGARY, Alberta, March 04, 2021 (GLOBE NEWSWIRE) -- FluroTech Ltd. (TSXV: TEST) (OTCQB: FLURF) (“FluroTech” or the “Company”), a leading developer of spectroscopy-based technology, together with joint venture FluroTest, LLC (“FluroTest”), a first-mover in surge-scale rapid antigen testing for the detection of SARS-CoV-2 and other pathogens, are pleased to announce that an agreement with Toolbox Medical Innovations (“Toolbox”) has been signed this week to carry out clinical trials of the FluroTest pandemic response platform alongside a comparator RT-PCR assay for performance detection of SARS-CoV-2 in saliva samples.
Toolbox Medical Innovations is an ISO 13485-certified consumables development firm and a full contract research organization (CRO) specializing in needs of the point-of-care diagnostic and life science industry. With a network consisting of over 100 clinical sites and over 50 combined years of clinical research and regulatory support, IVD product engineering and medical device usability testing experience, Toolbox is well-versed in simplifying and expediting the complex FDA approval procedures. Toolbox has a profound expertise in helping organizations surpass each step of the submission process from clinical study design and development, all the way up to regulatory planning and support, allowing them to provide a fast and efficient path to FDA and other approvals for IVD diagnostic products.
FluroTest will employ its pre-production testing platform developed with its partner Hudson Robotics. FluroTest is aiming to enroll approximately 600 volunteer participants, including both symptomatic and asymptomatic individuals. The clinical trials are anticipated to begin by mid-April. The data collected will be used to support FluroTest’s submission for Emergency Use Authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) and Health Canada for an Interim Order Authorization. Future submissions to additional regulatory bodies around the globe are also being considered.
“We continue to take measured steps in our execution and remain laser-focused on our objectives. This is a significant point in our path forward and we aim to ensure a smooth, timely, and accurate process,” said Bill Phelan, CEO of FluroTest. “Partnering with Toolbox allows us to leverage decades of clinical trial experience with professionals who have organized and executed clinical studies for Ellume and LumiraDx which have secured FDA EUA status. The goal of 600 participants, utilizing multiple clinical research institutions throughout North America, exceeds regulatory requirements. Suffice it to say our confidence and commitment to product validation remain strong. We believe the data endpoints will reflect favorably for our submission.”
“We are proud to bring decades of clinical trial, useability testing, regulatory and manufacturing experience to bear as we partner with FluroTest to conduct these clinical trials.” noted John Zeis, President of Toolbox Medical Innovations. “Enabling people to congregate in large venues such as stadiums, arenas, and large corporate environments safely and securely is critical to opening our economy. We are proud to be conducting clinical trials focused on enabling this.”
“With numerous research studies and trials to date, Toolbox is dedicated to bettering the medical community and enhancing population health. This dedication will ensure a stringent evaluation of our technology for the detection of the SARS-CoV-2 antigen in a clinical laboratory environment,” added FluroTech R&D Director and Senior Scientist, Dr. Mauricio Arias. “In collaboration with Toolbox’s research team, our clinical study is designed to surpass current FDA requirements for Emergency Use Authorization and is structured to demonstrate the efficacy of our antigen detection technology.”
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 in the process of applying for EUA approval from the FDA and Health Canada for an Interim Order Authorization.
The goal of FluroTech’s research and technology is to develop detection methods which are 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, has created a unique solution addressing the current and future pandemics. Using 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. FluroTech’s laboratory is led by Dr. Elmar Prenner, the original developer of the technology. Dr. Prenner serves as senior science advisor of FluroTech and brings over 28 years of expertise in fluorescence spectroscopy. 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 accurate 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
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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, 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 Systems Ltd which owns a 95% 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 Systems Ltd which owns a 95% interest in FluorTest 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.
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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.