ORIGINAL: Sona Nanotech Announces Clinical Evaluation Study Results for its COVID-19 Antigen Test
2020-08-25 13:34 ET - News Release
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.