Sona Nanotech Announces Clinical Evaluation Study Results for its COVID-19 Antigen Test
Halifax, Nova Scotia--(Newsfile Corp. - August 25, 2020) - Sona Nanotech Inc. (CSE: SONA), (OTCQB: SNANF) (the "Company"), a developer of rapid, point-of-care diagnostic tests, is pleased to announce that its rapid detection COVID-19 antigen test achieved a sensitivity of 84.6% and a specificity of 90.0% in a study across 99 collected clinical patient samples, which included 39 positive samples and 60 negative samples, as determined by RT-PCR testing. The Company is now continuing its submission of data to both the FDA and Health Canada to support their requirements for emergency use authorization approvals.
Darren Rowles, President and Chief Scientific Officer of Sona Nanotech comments, "Rapid, point-of-care, antigen tests can make a significant contribution to reducing the spread of COVID-19 by detecting the presence of the virus, potentially before the onset of symptoms. This achievement is the result of the extraordinary work and dedication by the entire Sona team and our partners."
The Company partnered with the King Fahd Research Center lab at King Abdulaziz University within SaudiVax, a life sciences joint venture between PnuVax Inc. of the United States and UYC Inc. of Saudi Arabia, to deliver the results of the study, which is complemented by previously released in-laboratory, analytical results from both the Company and MRIGlobal in Kansas City. Those latter evaluations determined test sensitivity of 96%, test specificity of 96% and a Limit of Detection ("LOD") of 2.1 x 102 TCID50. Clinical testing protocols are paramount as the CDC advises that proper collection of specimens is the most important step in the laboratory diagnosis of infectious diseases, whether the collection be for RT-PCR or rapid antigen tests, as swab application technique can strongly influence results.
Dr. Anwar Hashem, SaudiVax Chief Scientific Officer and the Deputy Director of King Fahd Medical Research Center at King Abdulaziz University commented, "As a leading medical research center, we have conducted clinical evaluation studies on several point-of-care antigen tests and found Sona Nanotech's rapid antigen test to perform by far the best, and we believe it could be a valuable addition to the existing diagnostic solutions needed to combat this pandemic."
The Company's rapid, antigen COVID-19 test utilizes a nasopharyngeal swab and provides a result in 15 minutes without the use of either laboratory equipment or a reader.
The Company cautions that its COVID-19 rapid antigen test is not yet approved by the FDA or other regulatory bodies and will update the market as appropriate. 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) at this time.
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 Nanotech'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.
About SaudiVax Ltd.
SaudiVax is a leading biotechnology company in the Kingdom and a joint venture of "UYC Inc." of Saudi Arabia and "PnuVax Inc." of the USA. The objective of SaudiVax is to localize biotechnology in Saudi Arabia, the Gulf Cooperation Council (GCC), & the Organisation of Islamic Countries (OIC). SaudiVax is particularly keen to ensure national health security by supporting the region's pandemic preparedness plans against infectious diseases. In alignment with the SaudiVision 2030, SaudiVax is promoting women employment in the biotechnology sector, and supporting the creation of high-income jobs for highly educated and talented Saudi graduates. SaudiVax is striving to be the 1st local manufacturer for "high demand" biotechnology products, creating a label in Saudi Arabia, and for exporting to the OIC members, to build needed ecosystems covering research, development, education, and training to secure technology and knowledge transfer. SaudiVax is led by Dr. Donald Gerson, Prof. Mazen Hassanain, Eng. Jonas Gerson with a group of elite Saudi scientists' collaborators.
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. 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.
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