The US Food and Drug Administration has rejected Sona Nanotech’s (CSE: SONA) request for an emergency use authorization for the marketing of its rapid COVID-19 antigen test. The device has been labeled as not being a priority at this time by the department, with the result being that no emergency use authorization is being granted.
The performance of the test was apparently not commented on, however the ruling is certainly a setback for the company. In terms of the Canadian market, Health Canada is reportedly continuing with its evaluation of Sona’s application for an interim order authorization, with further follow up conducted by the agency just yesterday.
The company has sold test kits in Canada already under “research use only” labelling as it works through acquiring the necessary approvals from the government agency. The company had developed the device as a means to provide a screening tool for identification of the virus among employees.
Despite the massive setback from the FDA, the company has continued with its manufacturing scale-up activities, although the potential market size has significantly been reduced in the near term. Multiple pilot production batches are said to have been completed with a contract manufacturing organization, while discussions continue with other manufacturers as well. Sona currently anticipates shipping test kits in November, which remains subject to regulatory approval.
Finally, the company has released analytical results from recent MRIGlobal and in-field clinical trial results with SaudiVax on its website to prvide further background data on the tests performance. The company is also working towards developing the second generation of its rapid COVID-19 antigen test which will use saliva samples.
Sona Nanotech last traded at $2.90 on the CSE, down 61.59% on this mornings development.
Information for this briefing was found via Sedar and Sona Nanotech. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.
2 Responses
This is misleading as rejection and deprioritization are two different things. Their test passes the thresholds for approval.
They were rejected for emergency use authorization, as the title says. Thats why they are “deprioritized” – their product does not qualify for the emergency use lane. Thus, they were rejected for this authorization.