(“FluroTech” or “the Company”) is pleased to provide an update to its press releases dated April 16 and 20, 2020 in respect of FluroTest LLC (“FluroTest”), formed through a strategic agreement with the Company, Alberta BioPhotonics Inc. (“ABP”) and Albany Medical College (“AMC”) today confirmed successful function of its novel and proprietary low-cost, real-time, point-of-care saliva-based immunoassay for detecting active SARS-CoV-2 infections.
The science behind the FluroTest virus direct detection method is based on a vertical flow immunoassay configuration which utilizes fluorescence spectroscopy to quantitatively determine SARS-CoV-2 viral load in salivary samples. Prototype testing was conducted at Albany Medical College’s immunology laboratories in Albany, New York supported by FluroTech’s Calgary Laboratory.
FluroTest intends to immediately begin the process of seeking Emergency Use Authorization (“EUA”) status from the U.S. Food and Drug Administration (“FDA”) in order to commercialize its pandemic platform solution. FluroTest will better understand the costs, time requirements, and next steps for commercialization once the FDA provides further guidance.
The FluroTest solution is a saliva-based, point of collection diagnostic immunoassay designed for accurate, digitally verifiable results, delivered with high throughput capacity, which are transmitted to a secure, managed, cloud environment compliant with the standards for privacy of individually identifiable health information as promulgated in the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).
By combining and leveraging the disciplines of robotics automation, biochemistry (antibody labeling and binding), fluorescence detection and cloud computing, FluroTest believes that it is creating the first pandemic defense platform of its kind. FluroTest anticipates a single platform installation could serve over 3,000 test takers per hour with digitally verifiable results transmitted to a secure, managed, HIPAA compliant cloud environment and immediately available to the test taker’s mobile device within 5 minutes. The platform is intended to make it possible to test up to 100% of a specific community population every 4 to 7 days at a low cost to the test taker and high value to the communities served by the platform.
FluroTest believes that its pandemic defense platform can benefit organizations serving large, concentrated populations and bearing significant pandemic risk, forcing them to incur consequential business disruptions and closures. Examples include, but are not limited to: colleges and universities, hospitals & large healthcare complexes, athletic stadiums & large performance venues, corporate campus environments, large office buildings & complexes, shopping malls and centers, retail working warehouses, factories, food processing plants, airlines, as well as any public transportation hub such as subway entrances and airport terminals.
FluroTest believes its technology can also be adapted to allow for the detection of specific anti-SARS-CoV-2 human antibodies, potentially confirming the development of immunity.
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. In addition, FluroTest requires additional capital in the near-term to further the development and deployment of its testing device and will be seeking equity investors and is exploring strategic partnerships in connection with the same.
FluroTest’s technology development efforts require unique expertise in spectroscopy and fluorescence as well as immunology and virology. This initiative is a collaborative effort between U.S. and Canadian scientists with deep experience in their respective fields.
For immunology and virology expertise, FluroTest has partnered with Albany Medical College’s immunology and microbial disease department. AMC is located in the State of New York. The Department’s research team is led by Dennis Metzger, Ph.D., professor and chair of the department, along with assistant professor Kouacou Konan, Ph.D., who is working with FluroTech to develop the technology. Dr. Konan’s research program concentrates on virus detection and the mechanisms responsible for viral disease pathogenesis. The program is supported by a Biosafety Level 3 laboratory that allows for the use of highly virulent pathogens and is one of the few such facilities in the state of New York. Dr. Konan has obtained approval for COVID-19 work in his Biosafety Level-3 laboratory. As part of Albany Medical Center, the only academic medical center and Level 1 Trauma Center serving northeastern New York and western New England, Albany Medical College is in a unique position to begin large scale sample collection and clinical trials which will assist in obtaining regulatory/FDA approvals. “My colleagues and I look forward to continuing our collaboration on antibodies with the science team of FluroTech led by Dr. Mauricio Arias and on fluorescence spectroscopy with Dr. Elmar Prenner from the University of Calgary,” noted Dr. Konan. “This initiative enriches our mission of patient care, research and education—three critical factors to address this difficult viral problem for the people we serve.”
FluroTech has a long-standing collaboration on fluorescence spectroscopy with Dr. Elmar Prenner. Dr. Prenner is the original developer of the core technology which is owned by Alberta BioPhotonics. Dr. Prenner, a professor at the University of Calgary within the department of Biological Sciences, serves as senior science advisor of FluroTech and brings over 28 years of expertise in fluorescence spectroscopy.
Elmar Prenner, Ph.D. and Senior Science Advisor of FluroTech, Mauricio Arias, Ph.D. and Kouacou Konan, Ph.D., have helped prepare and approve the proof of concept documentation that is summarized in this press release.
About Albany Medical Center
Albany Med, northeastern New York’s only academic health sciences center, is one of the largest private employers in the Capital Region. It incorporates the 766-bed Albany Medical Center Hospital, which offers the widest range of medical and surgical services in the region, and Albany Medical College, which trains the next generation of doctors, scientists and other healthcare professionals. It also includes a biomedical research enterprise and the region’s largest physician’s practice with more than 500 doctors. Albany Med works with dozens of community partners to improve the region’s health and quality of life. For more information: www.amc.edu.
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 comprised of its CompleTest™ platform technology and consumable testing kits. Its accuracy has been independently validated. FluroTech continues to develop additional applications for the CompleTestTM platform technology. To learn more, visit FluroTech.com
About FluroTest LLC
FluroTest is seeking additional capital in the near-term and will also be exploring strategic partnerships with manufacturing and distribution companies to advance the deployment of the new test that’s being developed. To learn more, visit FluroTest.com
About Alberta BioPhotonics Inc.
Alberta BioPhotonics Inc. focuses on identifying market opportunities to commercialize its proprietary spectroscopy-based technology. ABP is controlled by some of the same officers and directors as FluroTech and currently holds approximately 33% of the common shares of FluroTech.
Albany Medical College
Amy M. Johnson
William P. Phelan
Chief Executive Officer
Director & EIR, Biomedical Acceleration and Commercialization Center
Chief Executive Officer
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.
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 formation of FluroTest and the capital structure thereof, the ability to adapt FluroTech’s CompleTestTM platform technology to test for viruses, including COVID-19, as well as accurately determining viral load, the ability to adapt the technology to allow for the detection of specific anti-SARS-CoV-2 human antibodies in a patient’s blood sample, and the speed and accuracy of such testing, the need for financing of FluroTest in the near term and the formation of strategic partnerships for the deployment and distribution of the technology. The Company made certain material assumptions, including but not limited to prevailing market conditions and general business, economic, competitive, political and social uncertainties, as well as the ability to adopt the CompleTestTM technology as described herein in a timely manner and to obtain the financing 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” and the failure to adapt the CompleTestTM technology as contemplated herein in a timely manner or at all, the risk that competitors will develop a similar or superior testing platform, the technology not having the anticipated testing benefits, the inability of FluroTest to obtain the necessary financing to achieve its purpose on satisfactory terms or at all, the failure to form strategic partnerships necessary to deploy and distribute the technology. 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.