Spartan Bioscience says Health Canada approves rapid COVID-19 test
Regulator approved Ottawa-based company's test after design improvements made
Ottawa-based Spartan Bioscience has received Health Canada approval for its made-in-Canada rapid COVID-19 test, authorizing the sale of the device.
"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," a news release from the company states.
The test offers hope because it is one of only a handful of approved quick-result tests that uses the polymerase chain reaction (PCR) testing method — widely considered the gold standard for accurate COVID-19 diagnostics — at the point-of-care, without the need to send anything to a lab.
The Spartan test isn't the first point-of-care PCR test to be approved in Canada, but it is the first to be made by a Canadian company with plans to sell solely to the Canadian market.
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.
WATCH | Health Canada approves Canadian-made rapid COVID-19 testing system:
"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 last 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 tests per week, but it 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.
"Everything that we produce here today, we are going to be shipping internally within Canada to all of our Canadian accounts," he said. "So we're a dedicated supply chain to the Canadian market."
- This story has been updated to clarify that this is not the first rapid PCR test to be available in Canada, as a statement from the company had earlier suggested.Jan 24, 2021 12:02 PM ET