Halifax, Nova Scotia--(Newsfile Corp. - May 19, 2022) - Sona Nanotech Inc. (CSE: SONA), (OTCQB: SNANF) (the "Company" or "Sona") announces the termination of its licensing agreement with Arlington Scientific for the Company's COVID-19 rapid saliva test following its analysis of data from two clinicial studies and consultations with the U.S. Food and Drug Administration ("FDA"). The studies included assessments of the test for both point-of-care ("POC") and for self-testing.
The test achieved sensitivity of 88% in a POC environment for patients with high enough viral loads to deem them contagious (ie. with RT-PCR cycle threshold ("Ct") counts below 30). The overall sensitivity measure, however, including all patients in the study, was 62%, below the required 80% threshold due to the relative number of patients enrolled in the study with Ct counts over 30. As a result, the test worked well with contagious subjects but not as well with subjects whose viral load was low. This study showed specificity of 94%. The self-test study generated overall sensitivity and specificity of 70% and 81%, respectively, whereas FDA guidelines call for a minimum specificity in the mid- to high 90's.
"Our novel COVID-19 saliva test produced strong results with contagious patients when administered by professionals, but due to a combination of deteriorating market dynamics and an FDA preference for over-the-counter testing options, the company will not be continuing with this program. While it is understood that Omicron presents first in saliva and therefore a logical test, saliva is an inherently tricky matrix as evidenced by the fact that no rapid saliva test has yet been approved by the FDA. We are disappointed in this outcome despite having achieved encouraging success with contagious patients," said David Regan, CEO, Sona Nanotech.
The Company will continue to focus its efforts on the development of its concussion and bovine tuberculosis rapid tests, as well as the development of its proprietary gold nanorod manufacturing technology. The Company is pleased to announce the initiation of a research and development study of this technology at Dr. Warren Chan's Integrated Nanotechnology & Biomedical Sciences Laboratory under the previously announced MOU with the University of Toronto. This study will examine the biocompatibility of Sona's proprietary, gold nanorod manufacturing processes which is expected to provide a foundation for further research into how Sona's technology can help to unlock new, medical nanotechnology applications.
The Company is also pleased to announce that the class action suit filed in the U.S. has been dismissed, with prejudice, and the deadline for filing an appeal has passed with no appeal filed.
David Regan, CEO
1 902 536 1932
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.
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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, including the risk that Sona may not be successful in identifying biomedical applications for its technology with adequate market potential or at all. 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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