After facing months of delays, Ottawa’s Spartan Bioscience is hoping its rapid COVID-19 testing device is poised to clear the final hurdle before it can go to market.
Spartan said this week it has officially re-submitted its much-anticipated Spartan Cube – a coffee cup-sized mini test lab that is expected to deliver results in less than an hour – to Health Canada for regulatory review.
It’s the final step in a rigorous process to clear the device for widespread use. The company said that once Health Canada has given it the green light, it will “immediately” begin shipping the tests to its commercial and government customers.
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“Our team has worked incredibly hard to deliver an accurate, easy-to-use, on-site rapid COVID testing system,” CEO Roger Eacock said in a statement.
“After conducting clinical trials, we are confident our efforts have paid off. We are grateful to our government and commercial partners across the country for supporting this made-in-Canada testing solution.”
Spartan said its recent clinical studies compared the Spartan Cube to “one of the most sensitive lab-based COVID-19 tests on the market today,” adding the studies were “successfully completed” in Canada and the U.S.
Getting to this point has been a bit of a circuitous journey for the local biotech firm.
After initially approving the test for emergency use in April, Health Canada said a few weeks later Spartan’s proprietary nasal swab wasn’t collecting sufficient amounts of the virus DNA from infected individuals to ensure accurate readings.
Production was suddenly halted, throwing into question hundreds of millions of dollars worth of sales to the federal, Alberta, Ontario and Quebec governments – which had ordered nearly two million test cartridges and the cubes that process them.
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Spartan’s engineers spent the next several months working day and night to refine the sampling process. In late October, Health Canada gave Spartan the go-ahead to begin clinical trials on symptomatic COVID-19 patients using the new method.
Last month, Eacock told OBJ he was confident the device would receive swift regulatory approval on both sides of the border once testing was completed, paving the way for the Spartan Cube to be sold around the world.
“Once we have Canada and the U.S., that’s going to open up a lot of the international market for us,” he said.
“Wherever there are delays getting products to market, it’s always a challenge. Spartan is very fortunate in that we have amazing partners at all levels of government who have supported us.”
