OTTAWA — Ottawa-based Spartan Bioscience says its rapid COVID-19 testing device has been approved by Health Canada after the company had to recall and resubmit its product last year.
The company had developed a portable device that promised to deliver rapid results and received federal approval in April 2020, but the device was recalled a month later after Health Canada expressed concerns about its effectiveness.
Spartan resubmitted its device for approval in mid-December, following several clinical trials in the U.S. and Canada, the company said.
On Saturday, Spartan Bioscience said in a statement that it had received Health Canada approval to sell its rapid testing device.
“The Spartan COVID-19 System offers the speed and ease of use of a rapid test, while using the technology of lab-based COVID-19 testing solutions,” the company said. “The Spartan system will be able to provide quality results to remote communities, industries and settings with limited lab access, helping relieve the burden on overwhelmed healthcare facilities.”
The company calls its Spartan COVID-19 System “the first truly mobile, rapid PCR test for COVID-19 for the Canadian market.”
Spartan says production of the testing devices has already begun and shipments to federal and provincial governments and to commercial partners would begin immediately.