Sixth Wave Innovations Inc. (CSE: SIXW) (OTCQB: SIXWF) (FSE: AHUH) ("Sixth Wave", "SIXW" or the "Company") is pleased to announce that its patent-pending Accelerated Molecularly Imprinted Polymer ("AMIPs™") technology has successfully detected the SARS-CoV-2 virus in saliva samples, at sensitivity levels comparable to commercially available antigen tests.
Low-cost, highly accurate, and simple to use testing will be extremely valuable to the global health community while high-density population areas remain susceptible to seasonal COVID-19 outbreaks and the predictable emergence of new variants. According to BCC Publishing, "the global market for COVID-19 diagnostic services was valued at $60.3 billion in 2020. The market should grow from $84.4 billion in 2021 to $195.1 billion by 2027, at a compound annual growth rate (CAGR) of 15.0% during 2021-2027.
Working with researchers at the world-renowned Li Ka Shing Institute of Virology at the University of Alberta ("Institute"), saliva samples spiked with live SARS-CoV-2 virus in a protocol similar to established ELISA clinical tests were performed. The battery of tests produced results down to published detection levels for antigen tests. Verified by Dr. Michael Joyce at the Institute, testing conclusively showed the virus binding directly to AMIPs™.
The ability to detect the virus in saliva samples is a critical diagnostic tool in the battle against the pandemic. The AMIPs™ technology provides an opportunity for less invasive, less expensive testing, without the limiting storage and handling requirements of an antigen test.
Moreover, the Company has successfully completed initial testing of Integration of the first microarray architecture into an AMIPs™ prototype. This advancement in the production of the polymer achieves another goal toward increased sensitivity and selectivity against other respiratory pathogens. Testing and optimization for production is ongoing. Initial viral selectivity screening experiments have validated AMIPs™ ability to screen between COVID-19 and other non-enveloped viruses.
Additionally, Research and Markets estimate that "the molecular diagnostics market is projected to grow at a CAGR of 12.1% during 2021-2028. The market growth is mainly attributed to an increase in demand for point-of-care devices and molecular diagnostics has wide applications in various indications such as oncology, infectious diseases, genetic testing, cardiac diseases, and immune system disorders."
"We have swiftly gone from a technology that was unknown in the diagnostics space to one that rivals immunoassay technology, one of the two entrenched technologies in the in vitro diagnostic market," said Dr. Garrett Kraft, Vice President of Innovations at Sixth Wave.
"The ability to detect the virus at levels comparable to commercially available antigen tests validates the usability of AMIPs™, both in clinical health settings and other use cases like the environmental monitoring of air and water."
SIXW is rapidly advancing additional sensitivity and cross-reactivity (selectivity against other respiratory pathogens) testing which, if they continue to show positive results, will put the Company in a position to begin preparations for independent clinical trials within the next 60-90 days. The Company is in discussions with multiple independent laboratories to perform clinical trials and provide the Company the requisite information to submit Emergency Use Authorization packages to Canada and the United States at a minimum. The Company has begun discussions with manufacturers and distributors preparing to manufacture prototypes for the clinical trials and proceed to mass manufacturing and distribution.
The Company is not making any express or implied claims that its current AMIPs™ product has the ability to eliminate, cure, contain, at a commercial level, COVID-19 (or SARS-2 coronavirus) at this time.
About Sixth Wave
Sixth Wave is a nanotechnology company with patented technologies that focus on extraction and detection of target substances at the molecular level using highly specialized Molecularly Imprinted Polymers (MIPs). The Company is in the process of a commercial rollout of its Affinity™ cannabinoid purification system, as well as IXOS®, a line of extraction polymers for the gold mining industry. The Company is in the development stages of a rapid diagnostic test for viruses under the Accelerated MIPs (AMIPs™) label.
Sixth Wave can design, develop, and commercialize MIP solutions across a broad spectrum of industries. The company is focused on nanotechnology architectures that are highly relevant for the detection and separation of viruses, biogenic amines, and other pathogens, for which the Company has products at various stages of development.
For more information about Sixth Wave, please visit our website at: www.sixthwave.com
ON BEHALF OF THE BOARD OF DIRECTORS
"Jonathan Gluckman"
Jonathan Gluckman, Ph.D., President & CEO
For information, please contact the Company:
Phone: (801) 582-0559
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Cautionary Notes
This press release includes certain statements that may be deemed "forward-looking statements" including statements regarding the planned use of proceeds and performance of the AMIPs™ technologies. All statements in this release, other than statements of historical facts, that address future events or developments that the Company expects, are forward-looking statements. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual events or developments may differ materially from those in forward-looking statements. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause the Company's actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. In particular, successful development and commercialization of the AMIPs™ technology are subject to the risk that the AMIPs™ technology may not prove to be successful in detecting virus targets effectively or at all, the uncertainty of medical product development, the uncertainty of timing or availability of required regulatory approvals, lack of track record of developing products for medical applications and the need for additional capital to carry out product development activities. The value of any products ultimately developed could be negatively impacted if the patent is not granted. The Company has not yet completed the development of a prototype for the product that is subject of its patent application and has not yet applied for regulatory approval for the use of this product from any regulatory agency.
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