Sona Nanotech Engages MRIGlobal for COVID-19 Test Validation Studies
May 22, 2020 – Halifax, Canada – Sona Nanotech Inc. (CSE: SONA), (OTCQB: SNANF) (the “Company”) is pleased to announce the engagement of MRIGlobal, a leading applied scientific research organization, to provide analytical and clinical validation studies for Sona’s COVID-19 rapid detection, point-of-care, antigen test which will be used for submission to Health Canada for regulatory approval and the FDA for Emergency Use Authorization (EUA). MRIGlobal has three ISO 9001, CLIA certified, and FDA compliant BSL-3 laboratories located throughout the United States and works with government and corporate clients from around the world.
The project work will take place in MRIGlobal’s Kansas City laboratories and will assess Sona’s test using live SARS-CoV-2 virus following its past, successful internal evaluation using gamma irradiated virus. The EUA studies will follow the FDA’s guidance for antigen testing, including assessments for sensitivity, specificity, cross-reactivity and interfering substances using patient samples and contrived (live viral culture) samples. The results of this assessment will be included as part of the Company’s regulatory submissions to Health Canada and the FDA for EUA approval.
Sona Nanotech CEO, Darren Rowles, commented, “We are delighted to be moving into the final validation process and looking forward to the potential of a test that can tangibly advance the safety and quality of life for our communities. Our lab team, in particular, deserves credit for their tremendous work in significantly progressing our antigen test prototype in a short period of time.”
Sona has received expressions of interest for tens of millions of its a COVID-19 rapid detection, point-of-care, antigen test and has secured non-binding letters of intent for 4.7 million of its tests, subject to test performance parameters and pricing. The Company has begun technology transfer activities with secured manufacturers and expects to begin taking deposits on letters of intent and expressions of interest following the completion and publishing of the validation results.
The Company cautions that its test is still an unvalidated prototype and will update the market as appropriate.
Sona Nanotech Inc.
About MRI Global
MRIGlobal addresses some of the world’s greatest threats and challenges. Founded in 1944 as an independent, non-profit organization, we perform contract research for government, industry, and academia. Our customized solutions in national security and defense and health include research and development capabilities in clinical research support, infectious disease and biological threat agent detection, global biological engagement, in vitro diagnostics, and laboratory management and operations. MRIGlobal is one of two partners in the Alliance for Sustainable Energy, LLC, which manages and operates the National Renewable Energy Laboratory (NREL) in Golden, Colorado, for the U.S. Department of Energy. For more information, visit mriglobal.org
About Sona Nanotech Inc.
Sona Nanotech Inc. is a nanotechnology life sciences firm that has developed multiple proprietary methods for the manufacture of various types of gold nanoparticles. The principal business carried out and intended to be continued by Sona is the development and application of its proprietary technologies for use in multiplex diagnostic testing platforms that will improve performance over existing tests in the market.
Sona’s gold nanorod particles are CTAB (cetyltrimethylammonium) free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. It is expected that Sona’s gold nanotechnologies may be adapted for use in applications, as a safe and effective delivery system for multiple medical treatments, pending the approval of various regulatory boards including Health Canada and the FDA.
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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain “forward-looking statements” under applicable Canadian securities legislation. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. 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. Sona disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.