HALIFAX: Sona Nanotech Inc. has been granted CE Mark status for its rapid, COVID-19 antigen test, a news release said.
The CE Mark declares the conformity of the Sona test with EU regulations and allows Sona to commercialize its test throughout Europe and potentially other territories in which the CE Mark is recognized.
The Company intends to begin selling its test as a screening tool for organizations wishing to screen individuals in high-risk congregate settings in which testing could quickly identify persons with a SARS-CoV-2 infection to inform infection prevention and control measures to reduce risk of transmission.
Individuals who have symptoms of COVID-19 or who have had close contact with someone with confirmed COVID-19 should be considered as candidates for screening. As a rapid screening test, all results should be assessed in the context of the local prevalence of the virus and considered ‘presumed’ positive or negative until confirmed by a physician.
With its CE Mark secured, the Company is now able to take firm orders in territories accepting a CE Mark and make corresponding manufacturing commitments from its contract manufacturer in the United Kingdom. The Company is currently also in the process of technology transfer to a second manufacturer, in North America. The Company will report quarterly on sales volumes and will update the market as material developments occur.
Sona’s rapid antigen test provides results in 15 minutes and is an immunochromatographic assay for the qualitative detection of the spike protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab specimens from individuals who are suspected of COVID-19. The assay is intended for professional use.
The Company continues to work with several potential partners to secure an additional clinical trial to support other potential regulatory submissions.
Any trial would require a sponsoring institution, a principal investigator, a study protocol, relevant medical ethics review board approval and Health Canada Investigational Testing Division approval. In advance of any such additional clinical trial, the Company continues to optimize its saliva-based prototype of its rapid, COVID-19 antigen test.