Sona Nanotech (SONA) is planning its next moves, following a series of upsets for its prospective COVID-19 rapid antigen test.
The company’s approval applications with the U.S. FDA and Health Canada have faced trouble this month, with the former downgrading the test’s application and the latter withdrawing the test pending further trial.
The news has devastated company’s TSXV-listed shares, which have lost nearly 90 per cent of value since early-October.
In a follow-up announcement today, the company revealed that Health Canada’s own commissioned review of the antigen tests brought up some discordant results, when compared to Sona’s private testing.
Specifically, the test showed 100 per cent sensitivity samples in Sona’s privately commission evaluation study, but only seven out of 39 positive samples were detected in Health Canada’s evaluation.
As a result, the company is now seeking additional data to amend the FDA and Health Canada submissions, but will use its existing data set to pursue certification in the EU and Saudi Arabia.
Commenting on the recent upsets, Sona Nanotech CEO David Regan said the development and understanding of rapid antigen tests has been a fluid and dynamic process over the nine months since this pandemic began.
“Sona Nanotech, leveraging its proprietary gold nanorod technology, has done the extraordinary in developing one of only a handful of such tests. While our regulatory road has not been straight forward, every entity that has evaluated our test has confirmed its ability to detect the COVID-19 virus and it achieved strong results from our in-field trials,” he added.
Sona Nanotech is down 3.39 per cent and is trading for C$1.14 per share at 1:27pm EST.