FluroTest Provides Clinical Trial Update for High Volume COVID-19 Rapid Antigen Testing System
FluroTech Ltd. (OTCQB: FLURF) has advanced its clinical trials for a rapid antigen testing system detecting SARS-CoV-2 across six U.S. sites, with 600 volunteers enrolled. This study aims to support Emergency Use Authorization submissions to the FDA and Health Canada. Toolbox Medical Innovations will assist in regulatory processes. CEO Bill Phelan emphasized the importance of the technology amid ongoing pandemic challenges. Despite achieving proof of concept, the technology is still pre-approval and cannot yet claim accurate detection of COVID-19.
- Enrollment of 600 volunteers across six states for an extensive clinical trial.
- Strong partnership with Toolbox Medical Innovations for regulatory support.
- Potential to expedite Emergency Use Authorization submissions with FDA and Health Canada.
- The testing method is still in the pre-approval stage.
- No claims can be made regarding the technology's ability to detect COVID-19 accurately.
Clinical Trial Progresses Across Six Clinical Site Locations Throughout the US
CALGARY, AB, May 10, 2021 /PRNewswire/ - FluroTech Ltd. (TSXV: TEST) (OTCQB: FLURF) and wholly owned subsidiary FluroTest Diagnostics Systems ("FluroTest" or The Company), a diagnostics technology leader in high output rapid antigen testing for the detection of SARS-CoV-2 and other pathogens, today announces the next phase of its ongoing clinical trials with its trial partner Toolbox Medical Innovations ("Toolbox").
The Company is pleased to report that approximately 600 volunteer participants, including both symptomatic and asymptomatic individuals, are being identified from six clinical site locations across California, Texas, Colorado, Rhode Island and Florida (with two sites) to determine performance detection results alongside a comparator RT-PCR assay. The data collected from this and the upcoming pilot program with California-based Total Testing Solutions (previously announced in the Company's news release dated May 3, 2021) will be used to support submissions for Emergency Use Authorization ("EUA") from the U.S. Food and Drug Administration ("FDA") and Health Canada for an Interim Order Authorization.
Toolbox has 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 diagnostic products. The 600-patient trial will be one of the most extensive conducted to date for FDA / Health Canada submissions.
Dr. Melina Cimler, Ph.D., CEO and Founder of PandiaDx LLC, remains actively engaged by FluroTest for regulatory guidance and services. A senior quality, regulatory, and in vitro diagnostic device expert with more than 30 years of experience in the life science and FDA-regulated diagnostic industry, Dr. Cimler is in close contact with key decision makers and is monitoring recent testing initiatives such as the Biden Administration's proposal to spend
"I am exceptionally proud and excited by the results that our team, including an A-list partner and advisor network, have produced over the course of the last few months in particular," said Bill Phelan, CEO, FluroTest Diagnostics Systems. "Navigating the evolving new normal requires innovative high throughput approaches that provide business and societal benefits on a world-wide scale. Despite global supply chain challenges, evolving regulations, and a society and economy in flux, we are still on track for meeting our targets for regulatory submissions and full-scale commercialization in Q2/Q3 2021. I believe FluroTest will soon emerge as society's point of access testing standard, and our supporters will benefit as a result."
FluroTest's high-volume antigen system is designed to facilitate very fast and accurate point of access testing of individuals by leveraging the disciplines of robotics automation, biochemistry, fluorescence detection and cloud computing. High-risk pandemic environments supported will include athletic stadiums and performance venues, airline and cruise ship terminals, corporate campuses, manufacturing facilities, schools and colleges, hospitals and large healthcare facilities, transportation and distribution hubs and other large businesses.
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. 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.
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 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 and public well-being, 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.
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
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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SOURCE FluroTech Ltd.
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