FluroTest Provides System Development Update; Reports Saliva-based Point of Access Test System and Immunoassay for SARS-CoV-2 Detection is Fully Functional

CALGARY, Alberta, Sept. 16, 2021 (GLOBE NEWSWIRE) -- 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 provided a progress update on efforts to bring its Pandemic Response Platform to market.

Notable product developments include:

  • Platform Development: FluroTest’s entire “end-to-end” Pandemic Response Platform is fully operational. This includes saliva collection kits, viral deactivation agents, the robotics automation test processing platform, the software operating the robotics automation platform, the immunoassay required to process saliva samples, and the microplate reader necessary to assess the presence of SARS CoV-2 from processed samples. The system is successfully obtaining readings for the presence of the virus. Three test processing platforms are fully functional and operating at NanoComposix, our immunoassay development partner; Toolbox, our clinical trials partner; as well as in the FluroTest Laboratories in Calgary. The system is processing 96 tests per batch at a time.
  • Platform Optimization Commencing: The Company is transitioning from platform development to commercial product optimization focused on accuracy of the test as well as throughput of the platform to prepare for the pre-clinical trial stage as well full clinical trials. The team is currently focusing on answering three questions. First, the level of effort required to optimize each step in the highly automated process. Second, the time required to complete each optimization step. Third, the capital required to accomplish this, along with successfully completing pre-clinical trials, clinical trials, and EUA submission to the FDA. This effort is being led by the management team as well as key advisors who are also significant shareholders in the Company.

Notable market developments include:

  • Vaccination / Weekly Testing Mandate: The Company has been closely reviewing the Biden administration’s new directive from the US Labor Department requiring all businesses with 100 or more employees to ensure their workers are either vaccinated or tested once a week. This policy is estimated to impact close to two-thirds of the American workforce, and businesses found not to be in compliance could face thousands of dollars in fines per employee.
  • Delta’s Impact and the Emergence of Other Variants: “I remain in regular contact with colleagues at the World Health Organization and other global public health agencies, discussing global seroprevalence levels as well as the impact and evolution of new variants driving mass transmission surges,” said Dr. Joxel Garcia, FluroTest Chief Medical Officer and Former US Assistant Health Secretary. “People who have been infected with or vaccinated against SARS-CoV-2 appear to have reduced risk of serious subsequent infection, but vaccine resistance combined with emerging variants have placed us in an unwinnable race to herd immunity. The concept is an optimistic but hollow soundbite. Science tells us we need to prepare for the long haul.”
  • Cases Remain High: The Associated Press reports that US cases have climbed back to levels not seen since last winter and CNN is reporting US hospitals are fighting against a sharp upward trend in cases and deaths.

“Elongated development timelines have been frustrating for everyone, but the team’s resolve to deliver a platform that will facilitate widespread point of access and surge-scale SARS-CoV-2 testing is unwavering,” said Bill Phelan, CEO of FluroTest. “The system is working and detecting the virus. Our approach is novel and the global need remains strong as it is now clear to the world that testing will be necessary for our lifetimes. As we continue to develop our end to end solution, it has been notable for us to find that there is no comparable solution available that is focused on the specific problems we are working to solve. The need for our solution in the environments we are focused on remains strong and is not being served. I appreciate the dedication of our team, the guidance provided by our shareholders/advisors, and the commitment by our investors as we develop a durable, long-term testing solution to address this important need.”

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 10 minutes. To learn more, visit FluroTest.com.  

For general FluroTech inquiries:

FluroTech Ltd.

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.

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.