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Spartan Bioscience Inc. has resubmitted its rapid COVID-19 test for Health Canada approval, months after the biotech company recalled its product when the regulator raised concerns over its efficacy.
The Ottawa-based company said in a statement Monday that its application includes results from clinical studies, which it says were successfully completed in both the U.S. and Canada.
“Our team has worked incredibly hard to deliver an accurate, easy-to-use, on-site rapid COVID testing system,” Spartan CEO Roger Eacock, who replaced co-founder Paul Lem in November, said in the statement. “After conducting clinical trials, we are confident our efforts have paid off.”
Spartan’s portable test kits received nationwide attention early on during the pandemic, as demand for rapid testing rose.
The company describes its Spartan Cube as a “DNA analyzer the size of a coffee cup,” which it claims can produce COVID-19 test results in less than an hour.
The federal government initially said in April that it had approved the rapid tests and the company began shipping them out.
Within weeks, however, Spartan voluntarily recalled 5,500 tests after Health Canada expressed concerns related to their effectiveness.
"While the Spartan system, the device, performed very well in a laboratory setting — along the specification the manufacturer had provided — it was in the clinical setting, the real-life setting, where it didn't perform well," Chief Public Health Officer Theresa Tam, said during a press conference on May 3.
At the time, Spartan said in a statement that the efficacy concerns were related to the swabs used in the test, as opposed to the portable analyzer device itself.
With its recent clinical studies completed, Spartan said it plans to begin shipping the tests to existing commercial and government partners once they're approved by Health Canada.