Sona Nanotech (SONA-Cse) Engages Mriglobal For Covid-19 Test Validation Studies
June 1st 2020 - NR
Sona Nanotech Inc. has engaged MRIGlobal, a leading applied scientific research organization, to provide analytical and clinical validation studies for Sona's COVID-19 rapid detection, point-of-care, antigen test which will be used for submission to Health Canada for regulatory approval and the FDA for emergency use authorization (EUA). MRIGlobal has three ISO 9001, CLIA-certified and Food and Drug Administration-compliant BSL-3 laboratories located throughout the United States and works with government and corporate clients from around the world.
The project work will take place in MRIGlobal's Kansas City laboratories and will assess Sona's test using live SARS-CoV-2 virus following its past, successful internal evaluation using gamma irradiated virus. The EUA studies will follow the FDA's guidance for antigen testing, including assessments for sensitivity, specificity, cross-reactivity and interfering substances using patient samples and contrived (live viral culture) samples. The results of this assessment will be included as part of the company's regulatory submissions to Health Canada and the FDA for EUA approval.
Sona Nanotech chief executive officer Darren Rowles commented: "We are delighted to be moving into the final validation process and looking forward to the potential of a test that can tangibly advance the safety and quality of life for our communities. Our lab team, in particular, deserves credit for their tremendous work in significantly progressing our antigen test prototype in a short period of time."
Sona has received expressions of interest for tens of millions of its COVID-19 rapid detection, point-of-care, antigen test and has secured non-binding letters of intent for 4.7 million of its tests, subject to test performance parameters and pricing. The company has begun technology transfer activities with secured manufacturers and expects to begin taking deposits on letters of intent and expressions of interest following the completion and publishing of the validation results.
The company cautions that its test is still an unvalidated prototype and will update the market as appropriate.
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.
Contact:
Sona Nanotech Inc.
David Regan
Strategic Advisor
+1.902.448.1416
About MRI Global |
