- Encouraging analytical test results did not translate to an ability to consistently detect the virus in clinical samples
- Company will focus resources on advancement of other rapid tests and further research with its proprietary gold nanorod technology
Halifax, Nova Scotia--(Newsfile Corp. - June 11, 2021) - Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company" or "Sona") a developer of rapid, point-of-care diagnostic tests announces that it is discontinuing its previously announced clinical trial of its COVID-19 rapid, antigen saliva test after a review of the interim results data, due to inadequate test sensitivity with clinical saliva samples and challenges with patient recruitment and enrollment into the study, as local prevalence of the virus has diminished significantly.
The study was designed to evaluate the ability to detect the COVID-19 virus in saliva samples using a novel collection device and a rapid antigen test cassette. The Company plans to focus its research strategy on continuing with its other rapid test development programs and research on its proprietary gold nanorod production technology.
Clinical trial principal investigator, Dr. David Jacobs of Humber River Hospital, comments "Unfortunately, as is often the case with prototypes, the early laboratory results did not translate well into the clinical environment. While there are many possible reasons for this discrepancy, the favored hypotheses are that either there is insufficient viral concentration in saliva, or there is an interfering substance in the saliva."
"We are disappointed that our COVID-19 test failed to demonstrate sufficient ability to detect the virus in saliva in clinical samples to warrant further investigation through this trial, but we are grateful to our collaborators at Humber River Hospital and to the volunteers in the trial," said David Regan, CEO, Sona Nanotech. "We are surprised that our clinical trial did not show a corresponding level of sensitivity to our laboratory studies which showed that our saliva test was able to detect gamma irradiated COVID-19 virus at clinically relevant levels. We were attempting to blaze a new and challenging trail in adding a less invasive, saliva-based rapid test to the arsenal of tests being used to detect the virus, something for which no other company has achieved an FDA EUA or Health Canada approval. We look forward to continuing further bold pursuits in new applications that leverage both our proprietary gold nanorod technology and the considerable base of experience afforded to us by our COVID-19 test development program."
Investor Relations Contact:
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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'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 development of rapid tests, including a rapid antigen test for COVID-19. 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 developing rapid tests using its gold nanorod technology that function at sufficiently high levels for market acceptance or at all, or if successfully developed, that Sona will obtain required regulatory approvals. 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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