Ottawa’s Spartan Bioscience says it’s received the green light from Health Canada to begin clinical trials on symptomatic COVID-19 patients aimed at finding a fix for its rapid virus test after the agency expressed concern earlier this year about the test’s effectiveness.
In a recent statement on its website, Spartan says the studies “will generate data to support our submission to gain authorization for the sale and distribution of the Spartan COVID-19 system in Canada.”
The company said it hopes to get Health Canada’s approval to market the test “in the coming weeks.”
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Spartan’s test involves inserting a cartridge containing a swab from a patient’s nose into a machine about the size of a coffee cup that analyzes DNA for the presence of the coronavirus. The company says the device can deliver accurate results in about an hour.
The federal government originally said it had approved the hand-held DNA analyzer in mid-April. Just weeks later, Spartan announced it was voluntarily recalling 5,500 tests that had been shipped nationally over concerns about the effectiveness of the proprietary swab used in the test, adding that Health Canada did not raise concerns about the accuracy of the test reagents or portable analyzer device.
The recall put a hold on Spartan’s plans to churn out thousands of the tests for customers including the federal government and the provinces of Ontario and Alberta, which had agreed to buy millions of dollars’ worth of the testing devices.
The federal government subsequently announced in late September it would buy 7.9 million rapid COVID-19 tests from U.S.-based Abbott Laboratories in a bid to take pressure off the country’s strained testing infrastructure.
The first shipment of 100,000 of the tests arrived in Canada in mid-October. The government said it expects another 2.4 million to arrive before the end of December and the rest in the new year.