FluroTest Announces Pre-Emergency Use Authorization Filing with FDA; Provides Executive Update on Program Progress
FluroTech LTD. (TSXV: TEST) (OTCQB: FLURF) and wholly owned subsidiary FluroTest Diagnostic 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 announced it has filed its Pre-Emergency Use Authorization (Pre-EUA) Request with the U.S. Food and Drug Administration (FDA). The Pre-EUA submission is the Company’s latest step taken as it seeks authorization of its FluroTest Pandemic Response Platform, designed to facilitate widespread point of access and surge-scale SARS-CoV-2 testing by leveraging the disciplines of robotics automation, biochemistry, fluorescence detection and cloud computing.
Notable updates include:
Pre-EUA Submission Delivery: Early engagement now progressing between FluroTest and the Agency to facilitate a speedy and fulsome final submission. These interactions help guide the FDA’s ability to review and potentially grant the EUA. As described by the FDA “A Pre-EUA package contains data and information about the safety, quality, and efficacy of the product, its intended use under a future or current EUA, and information about the emergency or potential emergency situation. The pre-EUA process allows FDA scientific and technical subject matter experts to begin a review of information and assist in the development of conditions of authorization, fact sheets, and other documentation that would be needed for an EUA in advance of an emergency and also helps to facilitate complete EUA requests during a current emergency declaration. “
Immunoassay Development: Positive results obtained on initial testing with the use of an inactivated virus. This is a critical step in immunoassay development. Final optimization of the buffer chemistry, to ensure optimal test performance with clinical samples from the field, is being performed. FluroTest immunoassay incorporates the same inactivation detergent that was also used in Gates Foundation funded immunoassays. Inactivation detergent is used in the sample collection device to make the saliva sample safe for transport, storage and handling.
Manufacturing: Pre-production development of three functioning pandemic defense platform systems is now complete. Newly added Biological Safety Cabinets have been built, tested, and approved for use.
Clinical Trial Update: Pending added guidance from the FDA on its pre-EUA submission, FluroTest will proceed with sample collections 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.
Customer Data and Privacy Protection – protocol now established and in place to manage test taker’s required data (e.g., name and link to the saliva sample, interface with all automated equipment and fluorescence reader, test results management, etc.)
“There’s simply no room for error in this process. We’re dealing with sophisticated testing equipment that we’ve engineered to be intuitive enough for a small team of operators to quickly and efficiently conduct high volume public testing. Equally sophisticated is the SARS-CoV-2 virus – now proving to be substantially more contagious and dangerous with the rise of the Delta and Lambda variants,” said Bill Phelan, CEO of FluroTest. “At my direction, I’ve instructed the scientific teams and all partners to spend the time required to fine-tune the system and have all details locked down and in proper working order. Vaccine levels are reportedly plateauing and unfortunately will not reach a tipping point. This virus will be with us for years and the world needs a mass testing solution to help meet this evolving threat and be prepared to face the inevitability of the next one. As we enter into an unprecedented transition period with see-sawing lock-downs and restriction lifts, the need to literally test these new waters remains high. As the virus gains greater exposure to a reopened population, we’re entering our approval home stretch and will not make the mistake of rushing to failure.”
FluroTest continues to work with clinical trials partner Toolbox Medical Innovations (“Toolbox”) to fulfill additional requirements to support final 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.
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.
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 10 minutes. To learn more, visit FluroTest.com.
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Danny Dalla-Longa, CEO
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.
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