Sona Nanotech Receives CE Mark Approval for its Rapid COVID-19 Antigen Test
Sona Nanotech Inc. (CSE: SONA), (OTCQB: SNANF) (the “Company”, “Sona”) a developer of rapid, point-of-care diagnostic tests, has been granted CE Mark status for its rapid, COVID-19 antigen test. The CE Mark declares the conformity of the Sona test with EU regulations and allows Sona to commercialize its test throughout Europe and potentially other territories in which the CE Mark is recognized.
The Company intends to begin selling its test as a screening tool for organizations wishing to screen individuals in high-risk congregate settings in which testing could quickly identify persons with a SARS-CoV-2 infection to inform infection prevention and control measures to reduce risk of transmission. Individuals who have symptoms of COVID-19 or who have had close contact with someone with confirmed COVID-19 should be considered as candidates for screening. As a rapid screening test, all results should be assessed in the context of the local prevalence of the virus and considered ‘presumed’ positive or negative until confirmed by a physician.
With its CE Mark secured, the Company is now able to take firm orders in territories accepting a CE Mark and make corresponding manufacturing commitments from its contract manufacturer in the United Kingdom. The Company is currently also in the process of technology transfer to a second manufacturer, in North America. The Company will report quarterly on sales volumes and will update the market as material developments occur.
Sona’s rapid antigen test provides results in 15 minutes and is an immunochromatographic assay for the qualitative detection of the spike protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab specimens from individuals who are suspected of COVID-19. The assay is intended for professional use.
The Company continues to work with several potential partners to secure an additional clinical trial to support other potential regulatory submissions. Any trial would require a sponsoring institution, a principal investigator, a study protocol, relevant medical ethics review board approval and Health Canada Investigational Testing Division approval. In advance of any such additional clinical trial, the Company continues to optimize its saliva-based prototype of its rapid, COVID-19 antigen test.
Sona recommends that users consult the CDC Interim Guidance for Antigen Testing for SARS-CoV-2: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 virus (or SARS-2 Coronavirus).
Investor Relations Contact:
604 684 6730 | 1 866 684 6730
About Sona Nanotech Inc.
Sona Nanotech 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 Nanotech’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 Nanotech’s gold nanotechnologies may be adapted for use in applications, as a safe and effective delivery system for multiple medical treatments, subject to the approval of various regulatory boards, including Health Canada and the FDA.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE CANADIAN SECURITIES EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain “forward-looking statements” under applicable Canadian securities legislation, including statements regarding Sona’s target market for its COVID-19 antigen test, expected timelines for manufacturing deliveries, technology transfer to a North American manufacturer, future sales reporting, and planned clinical trials and regulatory applications for its technology. 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, including the risk that Sona may not be successful in obtaining additional data necessary for regulatory approvals, or in obtaining required approvals once additional data is available, that potential customers may not adopt its products, that Sona’s saliva test technology may not prove to deliver the same level of testing accuracy and sensitivity as its nasopharyngeal swab-based test, that Sona may not be successful in identifying or reaching agreements with additional manufacturing partners, that Sona’s manufacturing partners are not able to scale up manufacturing of Sona’s products to the anticipated level, that raw materials may not be available in the amounts or on the schedules required to achieve Sona’s manufacturing targets, that Sona may not be able to obtain further clinical data, that Sona may not re-submit to the FDA and Health Canada, and that regulatory requirements may change. 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.
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