An Ottawa bioscience firm that recalled a rapid test for COVID-19 in May after Health Canada expressed concern about its effectiveness says it has fixed the problem and is preparing to reapply for regulatory approval of the devices.
In a recent statement on its website, Spartan Bioscience says the delay in rolling out the product gave it time to “incorporate the latest information on COVID-19 and conclude 12 weeks of intense work where we tested approximately 10,000 samples as part of our solution,” adding it plans to “re-engage in the regulatory approval process in Canada in the coming days.”
The company says it hopes to launch formal clinical studies of its product, known as the Spartan Cube, “as soon as possible” once Health Canada gives it the green light. Spartan said it is aiming to have the test ready for final approval by mid-fall.
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 and portable analyzer device.
Millions of dollars in sales
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. Meanwhile, Air Canada said last month it was working with the Ottawa company “to assess how best to employ” the Spartan Cube to screen passengers and airline employees.
A spokesperson said Spartan CEO Paul Lem would not be available for comment Thursday. In its recent statement, the company said it “understands the difficulties and frustrations that product approval delays have caused our government and private-sector partners.”
While noting that it has “allocated significant resources” to set up a new production facility in the Greater Toronto Area with a manufacturing partner, the company stressed that it “has not received full payments for any contracts.” The statement said Spartan would be fully compensated for the orders only after Health Canada has approved the tests and the products have been delivered.
“Spartan wishes to highlight that down payments from our partners have been critical in allowing us to scale test manufacturing capacity so that we are ready to mass produce immediately upon receipt of Health Canada approval,” the company added.