Ottawa-based company Spartan Bioscience has received Health Canada approval for its made-in-Canada rapid COVID-19 test, authorizing the sale of the device.
“Spartan’s test is the first truly mobile, rapid PCR test for COVID-19 for the Canadian market,” a news release from the company states. “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.”
Health Canada originally provided regulatory approval for the company’s device in April 2020 — with the federal government ordering 40,000 tests monthly. At the time, the portable test was being called a “game changer” by health officials because it could deliver on-location results within 60 minutes.
The federal agency restricted the device to research use in May, however, after finding problems with the test that made it unreliable. Approval was granted on Friday after the company conducted clinical trials based on a new device design, Health Canada spokesperson Natalie Mohamed told CBC News in an email.
“The Spartan Bioscience test is a point-of-care molecular test,” Mohamed wrote. “This new device meets Health Canada’s requirements for safety and effectiveness.”
New swab, upgrades to chemistry kit
Dr. James Spiegelman, a co-founder of the company who also practises internal medicine at Humber River Regional Hospital in Toronto, said the problems stemmed from the efficacy of the swabs used to collect tissue samples, not the machine itself.
Spartan originally used a proprietary cheek swab that it developed for other DNA diagnostics, he said, but it became clear that the swab wasn’t collecting enough genetic material to produce consistent, reliable results.
The company now uses standard nasopharyngeal swabs to collect tissue from the nose.
“We found that that provides the best sample for increased sensitivity of the test,” Spiegelman said.
Spiegelman said the company also made improvements to the sample processing kit so that it no longer needs to be shipped and stored at frozen temperatures but can be stored at room temperature.
With the Spartan test, a trained health-care professional swabs the nose of the person being tested, places the swab into a processing kit that generates a chain reaction and then puts that kit into the cube-shaped device, which takes about 50 minutes to analyze and produce results.
Spiegelman said the test could be used to provide quick and accurate COVID-19 diagnostics everywhere from hospitals and workplaces to pharmacies and remote communities.
“I think [Spartan’s rapid test] will really help alleviate and give us a tool in our toolbox to reduce the spread of COVID-19,” he said.
Rapid tests already in use across Canada
Rapid diagnostic tests are already in use in many settings across Canada to test for COVID-19, including in homeless shelters, long-term care homes and remote communities. Prime Minister Justin Trudeau said on Tuesday that the federal government had distributed more than 14 million to the provinces and territories.
“Hopefully we see these integrated into work environments, especially work environments where we know they’re at greater risk for outbreaks,” said infectious disease specialist Dr. Isaac Bogoch, who is also a member of the Ontario COVID-19 vaccine task force.
“I think you could think about certainly integrating them into certain schools or certain school settings, rural, remote, underserviced locations. There’s a lot of places where rapid tests would be extremely helpful.”
Spartan Bioscience CEO Roger Eacock said the company currently has the manufacturing capacity to produce 60,000 of the tests per week, but the company plans to ramp that up to 200,000 per week in the future.
Eacock said the company already has deals with the federal government and several provinces, as well as some airlines and resource companies, and that shipments are expected to begin in the coming week.