- Sona Nanotech (CSE:SONA) has revealed its rapid COVID-19 detection tests have a sensitivity of 96 per cent, prompting its market share to rise rapidly
- MRI Global, using live COVID-19 cultures, also determined the test can detect the virus in patients with a low viral load within 10 to 15 minutes
- The test will now go through in-field clinical trials in the US to determine its viability
- The company expects the clinical trials to be completed by the end of July, at which time it will apply for Health Canada and FDA emergency approvals
- Sona Nanotech (SONA) is up 78 per cent and is trading at C$5.60 per share
Sona Nanotech (CSE:SONA) has revealed its rapid COVID-19 detection tests have a sensitivity of 96 per cent, prompting its market share to rise.
MRI Global, using live COVID-19 cultures, determined the test can detect the virus in patients with a low viral load within 10 to 15 minutes.
Further in-house validation studies were also conducted by Sona Nanotech to assess the potential clinical performance of the test, using nasal samples from healthy patents, who were presumed negative for COVID-19.
Sales of the test will now be permitted through a research-only label until the company achieves full regulatory authorisation.
Sona will now enter into independent clinical in-field evaluation studies to generate the data needed to lobby for regulatory approval. The company will then need to submit to Health Canada the US FDA for emergency-use authorisation approvals.
Sona has already contacted a research organisation in the US and a university-affiliated laboratory to conduct the testing. Sona believes these tests will be completed by the end of July.
Darren Rowles, the CEO of Sona Nanotech called the results excellent and said the company is now looking to bring the rapid tests to market.
“This will allow expansion of testing by governments, help ease the burden on healthcare systems, keep healthcare workers safe by allowing them to know their status on a daily basis and assist in softening restrictions by providing a quick and simple means to screen individuals,” he said.
“Our team have worked tirelessly to bring this product to this point in a record time and my thanks goes out to all involved in progressing the test this far,” he said.
Sona Nanotech (SONA) is up 78 per cent and is trading at C$5.60 per share at 12:30 pm EDT.