Ottawa’s Spartan Bioscience says it has applied to Health Canada to begin clinical trials on a fix for its rapid COVID-19 test after the agency expressed concern earlier this year about the test’s effectiveness.
In a statement on its website late last month, Spartan says it was awaiting Health Canada’s approval to conduct “formal clinical validation studies” on upgrades to its Spartan Cube COVID-19 testing device. The company said it hopes to get the green light to market the Spartan Cube later this fall.
“We look forward to doing our part to improve COVID-19 testing capabilities and to help keep Canadians safe and productive during this pandemic,” the statement said.
Spartan’s test involves inserting a cartridge containing a swab from a patient’s mouth 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 as little as half 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 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.
Sales put on hold
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 announced last week 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.
Still, Health Canada has come under fire from some critics who say it waited too long to procure rapid tests. When asked recently if the department was being extra-cautious with approvals in the wake of earlier setbacks, Dr. Supriya Sharma, senior medical adviser to the department's deputy minister, said the Spartan case offered “lessons learned” for regulators.
Meanwhile, Air Canada said this summer it was also working with Spartan “to assess how best to employ” the Spartan Cube to screen passengers and airline employees. Then last week, the airline announced that it too was finalizing an order with Abbott for its rapid-test kits.