- Sona Nanotech (SONA) has revealed promising clinical evaluation study results for its rapid detection COVID-19 antigen test
- The study included 99 clinical patient samples, 39 of which were positive samples with the remaining 60 negative
- Results of the study demonstrated a sensitivity of 84.6 per cent and a specificity of 90 per cent
- The company is now progressing the submission of its data to both the FDA and Health Canada to support emergency use authorisation approval
- Sona Nanotech (SONA) is currently down 7.73 per cent and is trading at C$8.95 per share
Sona Nanotech (SONA) has revealed promising clinical evaluation study results for its rapid detection COVID-19 antigen test.
The study began in July this year but was delayed due to ethics review board approvals and a need to make study modifications to accommodate regulatory updates. These updates included renewed study enrolment criteria and assessments at point of care settings, as well as new test handling procedures.
Sona Nanotech’s test utilises a nasopharyngeal swab, which generates results within 15 minutes and without the need for specialised laboratory equipment.
With the evaluation study now complete, the test demonstrated a sensitivity of 84.6 per cent and a specificity of 90 per cent. A total of 99 clinical patient samples were collected, 39 of which were positive while the remaining 60 samples were negative.
Darren Rowles, President and CEO of Sona Nanotech, said the promising results were the result of extraordinary work undertaken by the company’s team and its partners.
“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,” he added.
Sona Nanotech partnered with King Fahd Research Centre lab at King Abdulaziz University within SaudiVax – a joint venture between US-based PnuVax Inc. and Saudi Arabia’s UYC Inc. – to deliver the study.
Dr. Anwar Hashem, Chief Scientific Officer of SaudiVax and the Deputy Director of King Fahd Medical Research Centre at King Abdulaziz University, noted the strong performance of Sona Nanotech’s test.
“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,” he said.
Sona Nanotech is now progressing the submission of its data to both the US Food and Drug Administration (FDA) and Health Canada to support its bid for emergency use authorisation.
Sona Nanotech (SONA) is currently down 7.73 per cent and is trading at C$8.95 per share at 3:02pm EDT.